LCIOADMT2: Lidocaine + Clonidine for Intraoral Anesthesia in Patients With Diabetes Mellitus Type 2

• Sponsor: University of Belgrade (Other)
• Overall Status: Completed
• CT.gov ID: NCT02371759
• Collaborator: (none)
• Enrollment: 256
• Location: 1
• Arms: 8
• Duration (Months): 31
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether 2% lidocaine (L) + clonidine (C) (15 mcg/ml) as a vasoconstrictor achieves efficient (equal or better parameters of intraoral local anesthesia in comparison to 2% lidocaine + epinephrine (E) (1:80 000)) and safe (stable cardiovascular parameters - systolic, diastolic, mean blood pressure and heart rate) intraoral local anesthesia in patients with Diabetes mellitus type 2.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus; Local Anesthesia	Drug: L+C maxillary anesthesia; Drug: L+C mandibular anesthesia; Drug: L+E maxillary anesthesia; Drug: L+E mandibular anesthesia	Phase 3

Detailed Description

Patients with diabetes mellitus type 2, represent a risk for performing regional anesthesia techniques due to microvascular (microangiopathy, neuropathy) and macrovascular (hypertension, coronary heart disease) complications. There is evidence that local anesthetic toxicity may be increased in diabetic setting due to underlying neuropathy; while interaction of diabetic blood vessels with vasoconstrictors may be of importance because of microangiopathic changes. Lately, regional anesthesia protocol in general surgery for patients with diabetes mellitus was released, proposing reduction of local anesthetic concentration and avoiding epinephrine as vasoconstrictor.

Oral cavity tissues in diabetes mellitus also suffer from neuropathy (burning, paresthesia, teeth loss, temporomandibular dysfunction, xerostomia) and microangiopathy (periodontal disease, salivary gland dysfunction). Most widely used vasoconstrictor for intraoral local anesthesia, epinephrine, is an alpha- and beta- adrenergic agonist. Because of its beta-adrenergic effects, epinephrine could adversely affect cardiovascular function, especially in risk patients. There are data suggesting that intraoral local anesthesia obtained with 2% lidocaine with clonidine, selective alpha 2-adrenoceptor agonist as a vasoconstrictor, is characterized with significantly more stable cardiovascular parameters and similar parameters of local anesthesia with respect to lidocaine with epinephrine in healthy and hypertensive patients.

With regard to aforementioned, the aim of this randomized double-blind controlled clinical trial is to evaluate and compare efficacy and safety of intraoral local anesthesia obtained with 2% lidocaine (L) + clonidine (15 mcg/ml) (C) or 2% L + epinephrine (1:80 000) (E), comparing healthy and diabetes mellitus type 2 patients. Prior to tooth extraction, random allocation to one of four groups (L+C maxillary infiltration, L+C mandibular block, L+E maxillary infiltration and L+E mandibular block) is performed for diabetic (30 per group) and healthy (30 per group) patients. Parameters of local anesthesia (onset, duration, intensity, width of anesthetic field for maxillary infiltration), cardiovascular parameters (systolic, diastolic, mean arterial pressure; heart rate and electrocardiographic changes), quality of postoperative analgesia (assessed by Visual Analogue Scale, Numerical Rating Scale and number of consumed analgesics) and postoperative complications (infection, bleeding, paresthesia, delayed wound healing) are evaluated and compared.

Study Design

• Study Type: Interventional
• Actual Enrollment: 256 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Efficacy and Safety of Intraoral Local Anesthesia by Lidocaine + Clonidine in Patients With Diabetes Mellitus Type 2
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diabetics: L+C maxillary anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia	Drug: L+C maxillary anesthesia; Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Experimental: Diabetics: L+C mandibular anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia	Drug: L+C mandibular anesthesia; Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Active Comparator: Diabetics: L+E maxillary anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia	Drug: L+E maxillary anesthesia; Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Active Comparator: Diabetics: L+E mandibular anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia	Drug: L+E mandibular anesthesia; Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Experimental: Healthy: L+C maxillary anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia	Drug: L+C maxillary anesthesia; Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Experimental: Healthy: L+C mandibular anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia	Drug: L+C mandibular anesthesia; Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Active Comparator: Healthy: L+E maxillary anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia	Drug: L+E maxillary anesthesia; Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Active Comparator: Healthy: L+E mandibular anesthesia Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia	Drug: L+E mandibular anesthesia; Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)

Outcome Measures

Primary Outcome Measures

1. Duration of Intraoral Local Anesthesia [Up to 6 hours after local anesthesia injection]

   Time until cessation in soft tissue numbness

2. Intensity of Intraoral Local Anesthesia [Up to 10 minutes after local anesthesia injection]

   Number of participants who reported values > 0 after pin-prick testing, using Visual Analogue Scale (VAS) and Numerical Rating Scale (NRS). VAS is represented by line 100 mm long, with one end marked with 0 and words "no pain" , while the other end is marked with 100 and words "the worst pain imanginable". VRS scale is represented by line 100 mm long, marked with numbers from 0 to 10, where 0 corresponds to "no pain", and 10 corresponds to "the worst pain imaginable". For both scales, higher scores represent worse outcomes.

3. Baseline Systolic Blood Pressure [Baseline, 0 minutes]

4. Systolic Blood Pressure at 10 Minutes [10th minute]

   Systolic blood pressure values 5 minutes after local anesthesia injection

5. Systolic Blood Pressure at 15 Minutes [15th minute]

   Systolic blood pressure values 10 minutes after local anesthesia injection

6. Systolic Blood Pressure at 20 Minutes [20th minute]

   Systolic blood pressure values 15 minutes after local anesthesia injection

7. Systolic Blood Pressure at 35 Minutes [35th minute]

   Systolic blood pressure values 30 minutes after local anesthesia injection

8. Baseline Diastolic Blood Pressure [baseline, 0 minutes]

9. Diastolic Blood Pressure at 10 Minutes [10th minute]

   Diastolic blood pressure values 5 minutes after local anesthesia injection

10. Diastolic Blood Pressure at 15 Minutes [15th minute]

    Diastolic blood pressure values 10 minutes after local anesthesia injection

11. Diastolic Blood Pressure at 20 Minutes [20th minute]

    Diastolic blood pressure values 15 minutes after local anesthesia injection

12. Diastolic Blood Pressure at 35 Minutes [35th minute]

    Diastolic blood pressure values 30 minutes after local anesthesia injection

13. Baseline Values of Heart Rate [baseline, 0 minutes]

14. Heart Rate at 10 Minutes [10th minute]

    Heart rate 5 minutes after local anesthesia injection, 10 minutes after baseline measurement

15. Heart Rate at 15 Minutes [15th minute]

    Heart rate 10 minutes after local anesthesia injection, 15 minutes after baseline measurement

16. Heart Rate at 20 Minutes [20th minute]

    Heart rate 15 minutes after local anesthesia injection, 20 minutes after baseline measurement

17. Ceart Rate at 35 Minutes [35th minute]

    Heart rate 30 minutes after local anesthesia injection, 35 minutes after baseline measurement

18. Baseline Electrocardiogram [baseline, 0 minutes]

19. Electrocardiogram at 10 Minutes [10th minute]

    ECG 5 minutes after local anesthesia injection, 10 minutes after baseline measurement

20. Electrocardiogram at 15 Minutes [15th minute]

    ECG 10 minutes after local anesthesia injection, 15 minutes after baseline measurement

21. Electrocardiogram at 20 Minutes [20th minute]

    ECG 15 minutes after local anesthesia injection, 20 minutes after baseline measurement

Secondary Outcome Measures

1. Onset of Intraoral Local Anesthesia [Up to 10 minutes, until subjective feeling of soft tissue numbnes]

   Evaluated by pin-prick after subjective feeling of soft tissue numbness appeared after local anesthesia injection

2. Width of Anesthetic Field After Maxillary Infiltration Anesthesia [Up to 10 minutes after injection of local anesthesia]

   Soft tissue numbness area determined by pin-prick test after maxillary infiltration anesthesia. Not tested for mandibular ablock anesthesia.

3. Postoperative Analgesia [up to 24 hours after tooth extraction]

   Number of participants who experienced postoperative pain, VAS, NRS

4. Local Postoperative Complications [24 hours, 7 days]

   Postoperative paresthesia by clinical examination

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Healthy participants: ASA I

• Diabetic type 2 participants: ASA III (HbA1c level < 9%)

• Required a single-root teeth indicated for non-complicated extraction

• Dental diagnosis of periodontal disease, tooth fracture, chronic periapical lesion and root infection

• Subjects give informed written consent

Exclusion Criteria:

• Pregnancy and lactation

• Allergy to used drugs and food

• Hepatic and/or renal failure

• ASA IV patients

• Tobacco smokers

• History of alcoholism and/or drug abuse and addiction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Dental Medicine, University of Belgrade	Belgrade		Serbia	11000

Sponsors and Collaborators

• University of Belgrade

Investigators

• Principal Investigator: Dragica DM Stojic, DDS, PhD, School of Dental Medicine, University of Belgrade
• Principal Investigator: Bozidar M Brkovic, DDS, PhD, School of Dental Medicine, University of Belgrade
• Principal Investigator: Marija S Milic, DDS, School of Dental Medicine, University of Belgrade

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bozidar Brkovic, DDS, MSc, PhD, Professor, Professor, DDS, MSc, PhD, University of Belgrade
• ClinicalTrials.gov Identifier: NCT02371759
• Other Study ID Numbers: UBelgrade 534/2; 175021
• First Posted: Feb 26, 2015
• Last Update Posted: May 3, 2017
• Last Verified: Mar 1, 2017

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Anesthetics

Study Results

Participant Flow

Recruitment Details	Participants recruited between june 2013 and december 2015 among the patients of Clinic of Oral Surgery, Faculty of Dental Medicine, University of Belgrade

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Period Title: Overall Study
STARTED	32	31	33	31	27	26	25	28
COMPLETED	29	30	32	31	24	25	25	24
NOT COMPLETED	3	1	1	0	3	1	0	4

Baseline Characteristics

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia	Total
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Total of all reporting groups
Overall Participants	29	30	32	31	24	25	25	24	220
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	29 100%	30 100%	32 100%	31 100%	24 100%	25 100%	25 100%	24 100%	220 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	22 75.9%	16 53.3%	21 65.6%	14 45.2%	9 37.5%	15 60%	15 60%	14 58.3%	126 57.3%
Male	7 24.1%	14 46.7%	11 34.4%	17 54.8%	15 62.5%	10 40%	10 40%	10 41.7%	94 42.7%
Region of Enrollment (participants) [Number]
Serbia	32 110.3%	31 103.3%	33 103.1%	31 100%	24 100%	25 100%	25 100%	24 100%	220 100%
Body Mass (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	78.72 (11.19)	75.03 (11.53)	85.84 (14.76)	79.45 (17.34)	79.50 (15.22)	74.59 (9.64)	71.01 (12.08)	71.59 (7.81)	76.90 (8.42)
Fasting Plasma Glucose (milimoles per liter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [milimoles per liter]	8.12 (3.01)	7.55 (2.53)	9.66 (4.02)	8.35 (2.49)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)
Duration of Diabetes (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	6.83 (4.59)	9.57 (5.51)	9.77 (7.62)	9.27 (6.09)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)
Glycosilated Hemoglobin (percents) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percents]	7.42 (1.25)	7.55 (2.53)	7.63 (1.72)	7.97 (1.50)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)
Number of participants with modified diet (Count of Participants)
Count of Participants [Participants]	22 75.9%	30 100%	31 96.9%	30 96.8%	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN
Number of participants on OHA therapy (Count of Participants)
Count of Participants [Participants]	28 96.6%	29 96.7%	30 93.8%	30 96.8%	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN
Number of participants on insulin therapy (Count of Participants)
Count of Participants [Participants]	2 6.9%	4 13.3%	8 25%	4 12.9%	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN
Hypertension (Count of Participants)
Count of Participants [Participants]	16 55.2%	26 86.7%	19 59.4%	17 54.8%	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN
Coronary Artery Disease (Count of Participants)
Count of Participants [Participants]	12 41.4%	14 46.7%	14 43.8%	13 41.9%	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN
Peripheral Neuropathy (Count of Participants)
Count of Participants [Participants]	9 31%	12 40%	12 37.5%	10 32.3%	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN
Intraoral Neuropathy (Count of Participants)
Count of Participants [Participants]	14 48.3%	16 53.3%	17 53.1%	18 58.1%	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN

Outcome Measures

1. Primary Outcome

Title	Duration of Intraoral Local Anesthesia
Description	Time until cessation in soft tissue numbness
Time Frame	Up to 6 hours after local anesthesia injection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Mean (Standard Deviation) [minutes]	132.48 (91.86)	173.27 (70.44)	182.09 (57.86)	195.35 (68.99)	108.82 (27.76)	155.59 (60.75)	114.74 (39.72)	172.91 (68.93)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetics: L+C Maxillary Anesthesia, Diabetics: L+C Mandibular Anesthesia, Diabetics: L+E Maxillary Anesthesia, Diabetics: L+E Mandibular Anesthesia, Healthy: L+C Maxillary Anesthesia, Healthy: L+C Mandibular Anesthesia, Healthy: L+E Maxillary Anesthesia, Healthy: L+E Mandibular Anesthesia
	Comments	In order to detect 20% difference in intraoral anesthesia duration between healthy and diabetic participants, with 80 % statistical power at a two-tailed significance level of 0.05 using Mann Whitney U test, it was calculated that at least 24 participants must be included in each group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	In order to detect 20% difference in intraoral anesthesia duration between healthy and diabetic participants, with 80 % statistical power at a two-tailed significance level of 0.05 using Mann Whitney U test, it was calculated that at least 24 participants must be included in each group
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Primary Outcome

Title	Intensity of Intraoral Local Anesthesia
Description	Number of participants who reported values > 0 after pin-prick testing, using Visual Analogue Scale (VAS) and Numerical Rating Scale (NRS). VAS is represented by line 100 mm long, with one end marked with 0 and words "no pain" , while the other end is marked with 100 and words "the worst pain imanginable". VRS scale is represented by line 100 mm long, marked with numbers from 0 to 10, where 0 corresponds to "no pain", and 10 corresponds to "the worst pain imaginable". For both scales, higher scores represent worse outcomes.
Time Frame	Up to 10 minutes after local anesthesia injection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Count of Participants [Participants]	2 6.9%	2 6.7%	1 3.1%	8 25.8%	2 8.3%	1 4%	4 16%	6 25%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetics: L+C Maxillary Anesthesia, Diabetics: L+C Mandibular Anesthesia, Diabetics: L+E Maxillary Anesthesia, Diabetics: L+E Mandibular Anesthesia, Healthy: L+C Maxillary Anesthesia, Healthy: L+C Mandibular Anesthesia, Healthy: L+E Maxillary Anesthesia, Healthy: L+E Mandibular Anesthesia
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Chi-squared
	Comments

3. Primary Outcome

Title	Baseline Systolic Blood Pressure
Time Frame	Baseline, 0 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Mean (Standard Deviation) [milimeters of Hg]	135.2759 (16.69665611)	137.7333 (18.43335308)	134.8125 (18.66934265)	134.4667 (17.69119729)	124.0455 (11.07325079)	128.1818 (15.49388931)	125 (11.11918898)	126.5909 (18.82322642)

4. Primary Outcome

Title	Systolic Blood Pressure at 10 Minutes
Description	Systolic blood pressure values 5 minutes after local anesthesia injection
Time Frame	10th minute

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Mean (Standard Deviation) [milimeters of Hg]	130.3793 (18.81377496)	136.8333 (14.27098173)	137.4375 (19.73033934)	132.6 (20.45858857)	120.8182 (13.58092627)	122.5909 (14.59503859)	125.8261 (13.75979708)	125,4091 (12.71541656)

5. Primary Outcome

Title	Systolic Blood Pressure at 15 Minutes
Description	Systolic blood pressure values 10 minutes after local anesthesia injection
Time Frame	15th minute

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Mean (Standard Deviation) [milimeters of Hg]	133.5862 (13.51590925)	133.4667 (14.12684735)	137.4688 (19.28058421)	132.0667 (17.89580957)	114.4545 (11.89128241)	116.9091 (12.78730431)	123.8696 (13.61250878)	127.1818 (18.58733917)

6. Primary Outcome

Title	Systolic Blood Pressure at 20 Minutes
Description	Systolic blood pressure values 15 minutes after local anesthesia injection
Time Frame	20th minute

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Mean (Standard Deviation) [milimeters of Hg]	130.2414 (14.98011819)	131.3333 (14.73755076)	132.4063 (17.69428443)	133.2333 (18.46560212)	108.8182 (9.529630256)	120.8636 (12.995587)	123.8696 (12.15918788)	124.6818 (19.56767588)

7. Primary Outcome

Title	Systolic Blood Pressure at 35 Minutes
Description	Systolic blood pressure values 30 minutes after local anesthesia injection
Time Frame	35th minute

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Mean (Standard Deviation) [milimeters of Hg]	127.2759 (12.91979807)	130.3 (13.12841089)	132.5625 (17.0330561)	132.7 (16.38723706)	116.3636 (7.364945637)	120.1364 (14.54809906)	120.6522 (10.01185069)	126.4545 (17.25916533)

8. Primary Outcome

Title	Baseline Diastolic Blood Pressure
Time Frame	baseline, 0 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Mean (Standard Deviation) [milimeters of Hg]	74.1379 (11.37894088)	81.7667 (9.722648048)	75.25 (12.09372004)	79.2 (15.61345574)	73.1364 (9.627814144)	80.9545 (11.23547644)	76.3913 (5.694807287)	75.0909 (12.72758194)

9. Primary Outcome

Title	Diastolic Blood Pressure at 10 Minutes
Description	Diastolic blood pressure values 5 minutes after local anesthesia injection
Time Frame	10th minute

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Mean (Standard Deviation) [milimeters of Hg]	74.0345 (8.398480979)	75.3667 (12.09830424)	75.6875 (14.74829132)	79.1 (15.23497999)	69.7273 (10.49798991)	75.0909 (6.560408603)	75.8261 (7.010720193)	73.8636 (10.14793178)

10. Primary Outcome

Title	Diastolic Blood Pressure at 15 Minutes
Description	Diastolic blood pressure values 10 minutes after local anesthesia injection
Time Frame	15th minute

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Mean (Standard Deviation) [milimeters of Hg]	72.6897 (6.876998142)	74.8 (9.672154605)	74.8125 (13.17729597)	80.0333 (13.86217876)	69.3636 (9.800609576)	72.5 (7.163066648)	79 (15.45374329)	74.1818 (11.57434093)

11. Primary Outcome

Title	Diastolic Blood Pressure at 20 Minutes
Description	Diastolic blood pressure values 15 minutes after local anesthesia injection
Time Frame	20th minute

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Mean (Standard Deviation) [milimeters of Hg]	71.6897 (7.865400945)	74.1667 (9.013718791)	74.1563 (11.65390527)	80.8333 (13.56465997)	69.4545 (6.200823853)	75.9545 (8.566141948)	77 (9.060403362)	76.0455 (14.81144111)

12. Primary Outcome

Title	Diastolic Blood Pressure at 35 Minutes
Description	Diastolic blood pressure values 30 minutes after local anesthesia injection
Time Frame	35th minute

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Mean (Standard Deviation) [milimeters of Hg]	70.1379 (8.140393716)	74.3667 (10.37021597)	73.2813 (12.59091935)	75.9 (12.29859279)	69.1364 (7.146730552)	77.0455 (7.587441207)	77.6087 (7.19051857)	74.7273 (8.446931357)

13. Primary Outcome

Title	Baseline Values of Heart Rate
Time Frame	baseline, 0 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Mean (Standard Deviation) [beats per minute]	75.0345 (10.80172856)	80.7727 (6.682366571)	78.3438 (10.20312847)	84.2581 (13.16806172)	76.4545 (14.44769638)	73.0333 (8.695547948)	76.2174 (14.04031463)	76.3636 (9.756782523)

14. Primary Outcome

Title	Heart Rate at 10 Minutes
Description	Heart rate 5 minutes after local anesthesia injection, 10 minutes after baseline measurement
Time Frame	10th minute

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Mean (Standard Deviation) [beats per minute]	75.3448 (11.45262248)	81.7727 (5.72311305)	83.3125 (10.35012077)	88.5806 (12.72209153)	74.0455 (15.06012481)	73.0667 (7.671417688)	83.913 (14.36811358)	83.6818 (13.23554508)

15. Primary Outcome

Title	Heart Rate at 15 Minutes
Description	Heart rate 10 minutes after local anesthesia injection, 15 minutes after baseline measurement
Time Frame	15th minute

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Mean (Standard Deviation) [beats per minute]	73.0345 (10.10828076)	77.4545 (6.790883003)	83.4688 (10.92196477)	86.8387 (12.41261932)	74.5 (12.91271061)	73.4333 (4.896327805)	81.6957 (14.48974013)	83.5909 (11.09121957)

16. Primary Outcome

Title	Heart Rate at 20 Minutes
Description	Heart rate 15 minutes after local anesthesia injection, 20 minutes after baseline measurement
Time Frame	20th minute

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Mean (Standard Deviation) [beats per minute]	72.2414 (9.697772839)	80.2273 (7.276477612)	81.3125 (11.56032565)	86.1935 (12.04552297)	73.6818 (12.32645766)	71.8667 (5.281881142)	79.8435 (13.46448997)	82 (11.84824681)

17. Primary Outcome

Title	Ceart Rate at 35 Minutes
Description	Heart rate 30 minutes after local anesthesia injection, 35 minutes after baseline measurement
Time Frame	35th minute

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Mean (Standard Deviation) [beats per minute]	72.1034 (9.236359934)	80.8182 (6.095127129)	80.0938 (11.04348991)	85.3871 (11.87062879)	71.3636 (12.53393662)	73.4333 (7.762157062)	77 (13.78017709)	78.2273 (12.75382974)

18. Primary Outcome

Title	Baseline Electrocardiogram
Time Frame	baseline, 0 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetics: L+C Maxillary Anesthesia, Diabetics: L+C Mandibular Anesthesia, Diabetics: L+E Maxillary Anesthesia, Diabetics: L+E Mandibular Anesthesia, Healthy: L+C Maxillary Anesthesia, Healthy: L+C Mandibular Anesthesia, Healthy: L+E Maxillary Anesthesia, Healthy: L+E Mandibular Anesthesia
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Chi-squared
	Comments

19. Primary Outcome

Title	Electrocardiogram at 10 Minutes
Description	ECG 5 minutes after local anesthesia injection, 10 minutes after baseline measurement
Time Frame	10th minute

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetics: L+C Maxillary Anesthesia, Diabetics: L+C Mandibular Anesthesia, Diabetics: L+E Maxillary Anesthesia, Diabetics: L+E Mandibular Anesthesia, Healthy: L+C Maxillary Anesthesia, Healthy: L+C Mandibular Anesthesia, Healthy: L+E Maxillary Anesthesia, Healthy: L+E Mandibular Anesthesia
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Chi-squared
	Comments

20. Primary Outcome

Title	Electrocardiogram at 15 Minutes
Description	ECG 10 minutes after local anesthesia injection, 15 minutes after baseline measurement
Time Frame	15th minute

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetics: L+C Maxillary Anesthesia, Diabetics: L+C Mandibular Anesthesia, Diabetics: L+E Maxillary Anesthesia, Diabetics: L+E Mandibular Anesthesia, Healthy: L+C Maxillary Anesthesia, Healthy: L+C Mandibular Anesthesia, Healthy: L+E Maxillary Anesthesia, Healthy: L+E Mandibular Anesthesia
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Chi-squared
	Comments

21. Primary Outcome

Title	Electrocardiogram at 20 Minutes
Description	ECG 15 minutes after local anesthesia injection, 20 minutes after baseline measurement
Time Frame	20th minute

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetics: L+C Maxillary Anesthesia, Diabetics: L+C Mandibular Anesthesia, Diabetics: L+E Maxillary Anesthesia, Diabetics: L+E Mandibular Anesthesia, Healthy: L+C Maxillary Anesthesia, Healthy: L+C Mandibular Anesthesia, Healthy: L+E Maxillary Anesthesia, Healthy: L+E Mandibular Anesthesia
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Chi-squared
	Comments

22. Secondary Outcome

Title	Onset of Intraoral Local Anesthesia
Description	Evaluated by pin-prick after subjective feeling of soft tissue numbness appeared after local anesthesia injection
Time Frame	Up to 10 minutes, until subjective feeling of soft tissue numbnes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	25
Mean (Standard Deviation) [minutes]	1.76 (0.87)	5.27 (2.12)	2.16 (1.08)	5.45 (2.64)	2.77 (1.11)	4.59 (2.58)	2.83 (0.83)	6.36 (2.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetics: L+C Maxillary Anesthesia, Diabetics: L+C Mandibular Anesthesia, Diabetics: L+E Maxillary Anesthesia, Diabetics: L+E Mandibular Anesthesia, Healthy: L+C Maxillary Anesthesia, Healthy: L+C Mandibular Anesthesia, Healthy: L+E Maxillary Anesthesia, Healthy: L+E Mandibular Anesthesia
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

23. Secondary Outcome

Title	Width of Anesthetic Field After Maxillary Infiltration Anesthesia
Description	Soft tissue numbness area determined by pin-prick test after maxillary infiltration anesthesia. Not tested for mandibular ablock anesthesia.
Time Frame	Up to 10 minutes after injection of local anesthesia

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Mean (Standard Deviation) [milimeters]	27.07 (1.06)	NA (NA)	35.19 (1.67)	NA (NA)	23.81 (1.07)	NA (NA)	24.52 (0.95)	NA (NA)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetics: L+C Maxillary Anesthesia, Diabetics: L+E Maxillary Anesthesia, Healthy: L+C Maxillary Anesthesia, Healthy: L+E Maxillary Anesthesia
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

24. Secondary Outcome

Title	Postoperative Analgesia
Description	Number of participants who experienced postoperative pain, VAS, NRS
Time Frame	up to 24 hours after tooth extraction

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Count of Participants [Participants]	11 37.9%	15 50%	13 40.6%	14 45.2%	5 20.8%	14 56%	10 40%	12 50%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetics: L+C Maxillary Anesthesia, Diabetics: L+C Mandibular Anesthesia, Diabetics: L+E Maxillary Anesthesia, Diabetics: L+E Mandibular Anesthesia, Healthy: L+C Maxillary Anesthesia, Healthy: L+C Mandibular Anesthesia, Healthy: L+E Maxillary Anesthesia, Healthy: L+E Mandibular Anesthesia
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Chi-squared
	Comments

25. Secondary Outcome

Title	Local Postoperative Complications
Description	Postoperative paresthesia by clinical examination
Time Frame	24 hours, 7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetics: L+C Maxillary Anesthesia	Diabetics: L+C Mandibular Anesthesia	Diabetics: L+E Maxillary Anesthesia	Diabetics: L+E Mandibular Anesthesia	Healthy: L+C Maxillary Anesthesia	Healthy: L+C Mandibular Anesthesia	Healthy: L+E Maxillary Anesthesia	Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Measure Participants	29	30	32	31	24	25	25	24
Count of Participants [Participants]	1 3.4%	1 3.3%	6 18.8%	4 12.9%	0 0%	0 0%	0 0%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetics: L+C Maxillary Anesthesia, Diabetics: L+C Mandibular Anesthesia, Diabetics: L+E Maxillary Anesthesia, Diabetics: L+E Mandibular Anesthesia, Healthy: L+C Maxillary Anesthesia, Healthy: L+C Mandibular Anesthesia, Healthy: L+E Maxillary Anesthesia, Healthy: L+E Mandibular Anesthesia
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	7 days
Arm/Group Title	Diabetics: L+C Maxillary Anesthesia		Diabetics: L+C Mandibular Anesthesia		Diabetics: L+E Maxillary Anesthesia		Diabetics: L+E Mandibular Anesthesia		Healthy: L+C Maxillary Anesthesia		Healthy: L+C Mandibular Anesthesia		Healthy: L+E Maxillary Anesthesia		Healthy: L+E Mandibular Anesthesia
Arm/Group Description	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)		Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)		Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)		Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)		Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)		Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)		Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)		Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
All Cause Mortality
	Diabetics: L+C Maxillary Anesthesia		Diabetics: L+C Mandibular Anesthesia		Diabetics: L+E Maxillary Anesthesia		Diabetics: L+E Mandibular Anesthesia		Healthy: L+C Maxillary Anesthesia		Healthy: L+C Mandibular Anesthesia		Healthy: L+E Maxillary Anesthesia		Healthy: L+E Mandibular Anesthesia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Diabetics: L+C Maxillary Anesthesia		Diabetics: L+C Mandibular Anesthesia		Diabetics: L+E Maxillary Anesthesia		Diabetics: L+E Mandibular Anesthesia		Healthy: L+C Maxillary Anesthesia		Healthy: L+C Mandibular Anesthesia		Healthy: L+E Maxillary Anesthesia		Healthy: L+E Mandibular Anesthesia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/30 (0%)		0/32 (0%)		0/31 (0%)		0/24 (0%)		0/25 (0%)		0/25 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Diabetics: L+C Maxillary Anesthesia		Diabetics: L+C Mandibular Anesthesia		Diabetics: L+E Maxillary Anesthesia		Diabetics: L+E Mandibular Anesthesia		Healthy: L+C Maxillary Anesthesia		Healthy: L+C Mandibular Anesthesia		Healthy: L+E Maxillary Anesthesia		Healthy: L+E Mandibular Anesthesia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/30 (0%)		0/32 (0%)		0/31 (0%)		0/24 (0%)		0/25 (0%)		0/25 (0%)		0/24 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.