The Anesthetic Efficacy of 3% Mepivacaine Plus 2% Lidocaine With 1:100,000 Epinephrine for Lower Jaw Dental Injections

• Sponsor: Ohio State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01574807
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief Summary

The inferior alveolar nerve block (shot) is the most frequently used injection technique for achieving local anesthesia (numbness) for the teeth in the lower jaw. However, this injection does not always result in successful pulpal (tooth) anesthesia (patient felt pain). No study has combined mepivacaine and lidocaine anesthetics (numbing solutions) for this type of injection (shot). The investigators propose to compare an injection of mepivacaine followed by lidocaine to an injection of lidocaine followed by lidocaine to determine if there is a difference in effectiveness.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: mepivacaine + lidocaine followed by lidocaine +lidocaine; Drug: lidocaine + lidocaine followed by mepivacaine + lidocaine	Phase 4

Detailed Description

One hundred adult male and female subjects will randomly receive two sets of inferior alveolar block injections (shots) consisting of; 1.) an injection of 1.8 mL of 3% mepivacaine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine, and 2.) an injection of 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine, at two separate appointments spaced at least two weeks apart, in a crossover design. Whether the subject receives the mepivacaine or the lidocaine for the first injection will be determined randomly. The doctor will not know whether the subject receives mepivacaine or lidocaine for the first injection. The subject will not know which anesthetics he/she receives. A pulp tester will be used to test the lower jaw teeth (molars, premolars, and incisors) for anesthesia (numbness) in 4-minute time cycles for 60 minutes. The data will be statistically analyzed.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Prospective, Randomized, Double-blind Study of the Anesthetic Efficacy of 3% Mepivacaine Plus 2% Lidocaine With 1:100,000 Epinephrine for Inferior Alveolar Nerve Blocks.
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mepivacaine + lidocaine followed by lidocaine + lidocaine A repeated measures design utilizing a single group of subjects was employed with each subject serving as his/her own control. Each subject received two interventions: 1.) 1.8 cc 3% mepivacaine and 1.8 cc 2% lidocaine with 1:100,000 epinephrine (3% mepivacaine/2% lidocaine with epinephrine - combination 1) and 2.) 1.8 cc 2% lidocaine with 1:100,000 epinephrine followed by 1.8 cc 2% liocaine with 1:100,000 epinephrine at two seperate appointments spaced 2 weeks apart.	Drug: mepivacaine + lidocaine followed by lidocaine +lidocaine; 1.8 mL of 3% mepivacaine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine; Other Names: Combo 1
Experimental: lidocaine + lidocaine followed by mepivacaine plus lidocaine A repeated measures design utilizing a single group of subjects was employed with each subject serving as his/her own control. Each subject received two interventions: 1.) 1.8 cc 2% lidocaine with 1:100,000 epinephrine and 1.8 cc 2% lidocaine with 1:100,000 epinephrine and 2.) 1.8 cc 3% mepivacaine and 1.8 cc 2% lidocaine with 1:100,000 epinephrine followed by 1.8 cc 2% liocaine with 1:100,000 epinephrine at two separate appointments spaced two weeks apart.	Drug: lidocaine + lidocaine followed by mepivacaine + lidocaine; 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 3% mepivacaine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine; Other Names: Combo 2

Outcome Measures

Primary Outcome Measures

1. Number of Participants Achieving Pulpal Anesthesia Success. [60 minutes per injection sequence.]

   An electric pulp tester will be used to test the lower jaw teeth (molars, premolars, and incisors) for anesthesia (numbness) in 4-minute time cycles for 60 minutes. Measurements of less than 80 on the EPT is considered not numb (anesthesia failure). Readings of 80 equate to anesthetic success.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• between the ages of 18 and 65 years

• good health (ASA classification I or II)

• able to provide informed consent

Exclusion Criteria:

• allergy to lidocaine or mepivacaine

• history of significant medical problem (ASA classification III or greater)

• depression

• have taken CNS depressants (including alcohol or any analgesic medications) within the last 48 hours

• lactating or pregnant

• inability to give informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University College of Dentistry, Postle Hall	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University

Investigators

• Principal Investigator: John Nusstein, DDS, MS, Chair, Division of Endodontics

Study Documents (Full-Text)

None provided.

More Information

Publications

• Cohen HP, Cha BY, Spångberg LS. Endodontic anesthesia in mandibular molars: a clinical study. J Endod. 1993 Jul;19(7):370-3.
• McLean C, Reader A, Beck M, Meryers WJ. An evaluation of 4% prilocaine and 3% mepivacaine compared with 2% lidocaine (1:100,000 epinephrine) for inferior alveolar nerve block. J Endod. 1993 Mar;19(3):146-50.
• Nusstein J, Reader A, Beck FM. Anesthetic efficacy of different volumes of lidocaine with epinephrine for inferior alveolar nerve blocks. Gen Dent. 2002 Jul-Aug;50(4):372-5; quiz 376-7.
• Rood JP, Caruana PE, Danford M, Pateromichelakis S. Prilocaine -- an investigation into its use in the presence of inflammation and in combination with lignocaine. J Dent. 1981 Sep;9(3):240-7.

• Responsible Party: John Nusstein, Associate Professor and Chair, Divison of Endodontics, Ohio State University
• ClinicalTrials.gov Identifier: NCT01574807
• Other Study ID Numbers: Endo-Lam2012
• First Posted: Apr 10, 2012
• Last Update Posted: Nov 17, 2020
• Last Verified: Nov 1, 2020

• Keywords provided by John Nusstein, Associate Professor and Chair, Divison of Endodontics, Ohio State University: mepivacaine; lidocaine; inferior alveolar nerve block; pulpal anesthesia; mepivacaine/lidocaine; lidocaine/lidocaine
• Additional relevant MeSH terms: Lidocaine; Mepivacaine

Study Results

Participant Flow

Recruitment Details	Recruitment occurred from august 2011 to May 2013 in the dental clinic of the College of Dentistry.
Pre-assignment Detail	No subjects were excluded from the study.

Arm/Group Title	Mepi/Lido + Lido/Lido Group	Lido/Lido + Mepi/Lido Group
Arm/Group Description	This group received Mepivacaine + lidocaine at 1st appointment and lidocaine + lidocaine at 2nd appointment.	This group received injections of lidocaine + lidocaine at 1st appointment and Mepivacaine + lidocaine at second appointment.
Period Title: First Appointment
STARTED	50	50
COMPLETED	50	50
NOT COMPLETED	0	0
Period Title: First Appointment
STARTED	50	50
COMPLETED	50	50
NOT COMPLETED	0	0
Period Title: First Appointment
STARTED	50	50
COMPLETED	50	50
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	All participants receive 3% mepivacaine + 2% lidocaine versus 2% lidocaine + 2% lidocaine injections in different randomized sequences.
Overall Participants	100
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	100 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	50 50%
Male	50 50%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Achieving Pulpal Anesthesia Success.
Description	An electric pulp tester will be used to test the lower jaw teeth (molars, premolars, and incisors) for anesthesia (numbness) in 4-minute time cycles for 60 minutes. Measurements of less than 80 on the EPT is considered not numb (anesthesia failure). Readings of 80 equate to anesthetic success.
Time Frame	60 minutes per injection sequence.

Outcome Measure Data

Analysis Population Description

Success of anesthesia was determined by subject achieving maximal level (80) with testing device by 5th testing time period (17 min.) following injection and maintaining that maximal response for the remainder of the testing time.

Arm/Group Title	Mepivacaine + Lidocaine	Lidocaine + Lidocaine
Arm/Group Description	Clinical appointment where: 1.8cc 3% mepivacine + 1.8cc 2% lidocaine is injected.	Clinical appointment where - 1.8cc 2% lidocaine + 1.8cc 2% lidocaine is injected.
Measure Participants	100	100
Count of Participants [Participants]	44 44%	40 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mepivacaine + Lidocaine, Lidocaine + Lidocaine
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.00
	Comments	Multiple McNemar tests corrected with Step-down Bonferroni method of Holm. A priori threshold for significance was 0.05.
	Method	McNemar
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	0
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Treatment Group
Arm/Group Description	3% mepivacaine/2% lidocaine with epinephrine - combination 1
All Cause Mortality
	Treatment Group
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Treatment Group
	Affected / at Risk (%)	# Events
Total	0/100 (0%)
Other (Not Including Serious) Adverse Events
	Treatment Group
	Affected / at Risk (%)	# Events
Total	0/100 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.