Success Rate of 4 Injection Protocols for Mandibular First Molars With Symptomatic Irreversible Pulpitis

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04929522
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Arms: 4
• Actual Duration (Months): 4.9
• Patients Per Site Per Month: 32.7

Study Details

Study Description

Brief Summary

Achieving profound anesthesia during endodontic treatment of mandibular molars with symptomatic irreversible pulpitis is still a demanding clinical challenge. therefore, the success Rate of 4 Injection protocols for Mandibular First Molars with Symptomatic Irreversible Pulpitis was evaluated clinically in a randomized triple-blind trial

Condition or Disease	Intervention/Treatment	Phase
Root Canal Infection	Procedure: local anesthesia	N/A

Detailed Description

Trial design This study was a prospective, randomized, parallel, triple blinded, clinical trial. The present trial design methodology conforms to the CONSORT guidelines for reporting randomized clinical trials.Participants A sample size calculation was performed based on the study by (Kanaa M, Whitworth JM, Meechan JG. A Prospective Randomized Trial of Different Supplementary Local Anesthetic Techniques after Failure of Inferior Alveolar Nerve Block in Patients with Irreversible Pulpitis in Mandibular Teeth. J Endod 2012;38:421-425). This research was based on a type I error of 0.05 and a power of 0.8 and indicated that ideally a sample size of 36 in each group would be required to detect a 20% difference in the success rate of the test groups. To increase the validity of the study, 40 subjects in each group were considered.Ethical considerations This trial was conducted with the approval of the institutional review of board (IRB) of the ethics committee at the Faculty of Dentistry, Ain Shams University, Cairo, Egypt (FDASU-REC 772019). Patients signed a printed informed consent form after explanation of the treatment procedure and associated possible adverse effects of the proposed interventions such as discomfort, pain, anesthetic failure and systemic side effects at this stage. Randomization To ensure random selection, participants were allocated randomly into four groups with1:1 allocation ratio by using computer generated randomization (www.randome.org). The sequence was therefore generated.

Allocation concealment mechanism: The sequentially generated numbers were placed in opaque envelopes until the intervention was conducted, and each participant was asked to select an envelope that determines which group of intervention was assumed.

Implementation: Co-researcher used computer generated randomization for participants who achieve eligibility criteria and accordingly participants were enrolled in either of the groups under study.

Blinding Both the participants, the operator who initiated endodontic treatment and monitored the pain, and the statistician were blinded to the anesthetic techniques used.

Intervention Diagnosis was confirmed through history reporting spontaneous pain, a moderate to severe painful response that persists after thermal stimulation, a prolonged response to cold testing with Endo-Ice (1,1,1,2 tetrafluoroethane; Hygenic Corp, Akron, OH), absence of percussion sensitivity and the periapical aspect of the tooth in the bidimensional periapical radiograph was normal. Matching vital contralateral teeth were also tested to ensure an accurate diagnosis and to serve as controls. To prevent bias, this diagnostic step was performed by one investigator (AH), while another investigator (DK) was responsible for administration of all anesthetic injections (DK), and a third investigator (SS) was responsible for root canal treatment procedures and pain recording. All investigators have a minimum of 12 years of clinical experience in endodontics.

One hundred and eighty-five patients consecutively visited were assessed for eligibility. Twenty-five patients were excluded for different reasons and the others (eighty-four female and seventy-six male patients) were allocated to the trial (Figure 1) and randomly assigned into 4 groups (n=40) as follows:

Group 1 (IANB): After determining the injection site and aspiration, 3.6ml of the anesthetic solution was administered using the standard inferior alveolar nerve block (IANB), this was considered the control group.

Group 2 (IANB + IO): A standard IANB was administered the same as for Group 1, followed by a supplemental intraosseous infusion (IO) injection using the Anesto system (W&H Dentalwerk Bürmoos, Austria). To ensure comfort during the procedure, 0.1ml of anesthetic solution was infiltrated at the perforation site using the standard syringe. The perforation site was selected near the junction of the attached and unattached gingival tissues, immediately distal to the first molar. Perforation was accomplished by operating the Anesto handpiece at full speed, with constant moderate pressure maintained until the perforator was felt to 'drop' into the cancellous bone. 1.8mL of the anesthetic solution was then deposited over a 60-second period. The Anesto handpiece was again retracted and, with the perforator rotating, removed from the injection site.

Group 3 (IANB + PDL): A standard IANB was administered the same as for groups 1 and 3, followed by a supplemental periodontal ligament (PDL) injection. The needle was wedged with force into the PDL space between the tooth and the alveolar crest of the bone, at 30-degrees to the long axis of the tooth. The thumb and index fingers of the left hand supported the needle to prevent buckling. The handle of the syringe was squeezed firmly until backpressure was achieved. Then a total of 1.8ml of the anesthetic solution were injected mesially and distally to the treated molar.

Group 4 (IANB + BI): A standard IANB was administered the same as for groups 1, 2 and 3, followed by a supplemental buccal infiltration at the buccal side of the affected tooth. A total of 1.8ml of the anesthetic solution were injected halfway the mesiodistal width of the clinical crown.

IANB, PDL and BI injections were performed with a conventional dental syringe (indicate the brand) and a 27-G needle at a rate of 2 mL/min. The anesthetic solution used for all techniques was Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain). The efficacy of anesthesia was determined by the following: (1) confirmation of lip numbness, (2) negative response to Endo-Ice, (3) negative response to the maximum output of the electric pulp tester (Parkell, Edgewood, NY, USA).

Root canal treatment procedure was later initiated, and the patients were asked to rate their pain using a visual analogue scale (VAS). Pain was scored as follows: Score 0, no pain; Score 1, mild pain; Score 2, moderate pain; or Score 3, severe pain. After rubber dam placement and during caries removal, access preparation and pulpectomy, success of the anesthetic technique was determined by VAS. The technique was considered as a 'success' when the patient reported no pain (VAS = 0 or 1) and as a 'failure' otherwise (VAS >1).

Heart rate changes were monitored with a finger pulse oximeter (Medlinket, Shenzhen Med-link Electronics, Shenzhen, China). It was recorded from 2 min before to 5 min after injection, at 30-s intervals. The mean heart rate for each injection was recorded.

Statistical analysis All analyses were undertaken with IBM SPSS Statistics (SPSS 26.0; SPSS Inc., Chicago, IL). The anesthetic success rates were analyzed using the chi-square test. Age differences were analyzed using One Way ANOVA, gender differences were analyzed using the Fischer Exact test while heart rate changes were analysed with Kruskal Wallis test, being non-normally distributed. Statistically significant differences were set at the P < 0.05 level

Study Design

• Study Type: Interventional
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This study was a prospective, randomized, parallel, triple blinded, clinical trial.This study was a prospective, randomized, parallel, triple blinded, clinical trial.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Allocation concealment mechanism: The sequentially generated numbers were placed in opaque envelopes until the intervention was conducted, and each participant was asked to select an envelope that determines which group of intervention was assumed.
• Primary Purpose: Treatment
• Official Title: Success Rate of 4 Injection Protocols for Mandibular First Molars With Symptomatic Irreversible Pulpitis: A CONSORT Randomized Triple-blind Clinical Trial
• Actual Study Start Date: Jan 1, 2021
• Actual Primary Completion Date: May 30, 2021
• Actual Study Completion Date: May 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: IANB/inferior alveolar nerve block patients will be given standard IANB with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain).	Procedure: local anesthesia; technique for local anesthesia
Active Comparator: IANB+IO patients will be given standard IANB plus an intra-osseous with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain).	Procedure: local anesthesia; technique for local anesthesia
Active Comparator: IANB+PDL patients will be given standard IANB plus a PDL injection with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain).	Procedure: local anesthesia; technique for local anesthesia
Active Comparator: IANB+BI patients will be given standard IANB plus a BI injection with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain).	Procedure: local anesthesia; technique for local anesthesia

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Successful Injection Technique Assessed by Verbal Rating Scale (VRS) [15 minutes from delivery of anesthesia]

   the patients were asked to rate their pain using a Verbal rating scale (VRS). Pain was scored as follows: Score 0, no pain; Score 1, mild pain; Score 2, moderate pain; or Score 3, severe pain. After rubber dam placement and during caries removal, access preparation and pulpectomy, success of the anesthetic technique was determined by NRS. The technique was considered as a 'success' when the patient reported no pain (VRS = 0 or 1) and as a 'failure' otherwise (vRS >1).

Secondary Outcome Measures

1. Changes in the Heart Rate Before, During and After the Injection [assessed from 2 min before to 5 min after injection (at 30-s intervals)]

   beat per minute measured by a finger pulse oximeter

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 49 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients included in the study were healthy males and females

• (Category: American Society of Anesthesiologists class 1)

• aged 21-49 years

• with no physical disability, facial paresthesia or psychological problems

• presenting with a single vital mature mandibular first molar, with signs and/or symptoms of symptomatic irreversible pulpitis

Exclusion Criteria:

• Pregnant women

• patients who took analgesics or other medications that would alter the inflammatory response of the pulp or provide analgesia 6- hours pre-operatively

• those with known sensitivity to the pharmaceuticals used in this trial.

• those with pathological periodontal pockets

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University	Cairo		Egypt

Sponsors and Collaborators

• Ain Shams University

Investigators

• Study Director: Ahmed Abdel Rahman Hashem, Ain Shams University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 5, 2021

More Information

Publications

None provided.

• Responsible Party: Shehab El Din Mohamed Saber, Professor, Ain Shams University
• ClinicalTrials.gov Identifier: NCT04929522
• Other Study ID Numbers: FDASU-REC IM061101
• First Posted: Jun 18, 2021
• Last Update Posted: Oct 7, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shehab El Din Mohamed Saber, Professor, Ain Shams University: intra-osseous injection; PDL injection; IANB
• Additional relevant MeSH terms: Pulpitis; Anesthetics

Study Results

Participant Flow

Arm/Group Title	IANB/Inferior Alveolar Nerve Block	IANB+IO	IANB+PDL	IANB+BI
Arm/Group Description	patients will be given standard IANB with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain). local anesthesia: technique for local anesthesia	patients will be given standard IANB plus an intra-osseous with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain). local anesthesia: technique for local anesthesia	patients will be given standard IANB plus a PDL injection with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain). local anesthesia: technique for local anesthesia	patients will be given standard IANB plus a BI injection with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain). local anesthesia: technique for local anesthesia
Period Title: Overall Study
STARTED	40	40	40	40
COMPLETED	40	40	40	40
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	IANB/Inferior Alveolar Nerve Block	IANB+IO	IANB+PDL	IANB+BI	Total
Arm/Group Description	patients were given a standard IANB with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain). local anesthesia: technique for local anesthesia	patients were given a standard IANB (1.8 ml) followed by an intra-osseous supplemental injection (1.8 ml) Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain). local anesthesia: technique for local anesthesia	patients were given a standard IANB (1.8 ml) followed by a PDL supplemental injection (1.8 ml) with Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain). local anesthesia: technique for local anesthesia	patients were given a standard IANB (1.8 ml) followed by a Buccal infiltration injection (1.8 ml) with Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain). local anesthesia: technique for local anesthesia	Total of all reporting groups
Overall Participants	40	40	40	40	160
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	40 100%	40 100%	40 100%	40 100%	160 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	25 62.5%	28 70%	26 65%	23 57.5%	102 63.8%
Male	15 37.5%	12 30%	14 35%	17 42.5%	58 36.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Egypt	40 100%	40 100%	40 100%	40 100%	160 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Successful Injection Technique Assessed by Verbal Rating Scale (VRS)
Description	the patients were asked to rate their pain using a Verbal rating scale (VRS). Pain was scored as follows: Score 0, no pain; Score 1, mild pain; Score 2, moderate pain; or Score 3, severe pain. After rubber dam placement and during caries removal, access preparation and pulpectomy, success of the anesthetic technique was determined by NRS. The technique was considered as a 'success' when the patient reported no pain (VRS = 0 or 1) and as a 'failure' otherwise (vRS >1).
Time Frame	15 minutes from delivery of anesthesia

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IANB/Inferior Alveolar Nerve Block	IANB+IO	IANB+PDL	IANB+BI
Arm/Group Description	patients were given a standard IANB with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain). local anesthesia: technique for local anesthesia	patients were given a standard IANB (1.8 ml) followed by an intra-osseous injection with 1.8 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain). local anesthesia: technique for local anesthesia	patients were given standard IANB (1.8 ml) followed by a PDL injection with 1.8 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain). local anesthesia: technique for local anesthesia	patients were given a standard IANB )1.8 ml) followed a Buccal Infiltration injection with 1.8 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain). local anesthesia: technique for local anesthesia
Measure Participants	40	40	40	40
Count of Participants [Participants]	16 40%	37 92.5%	29 72.5%	26 65%

2. Secondary Outcome

Title	Changes in the Heart Rate Before, During and After the Injection
Description	beat per minute measured by a finger pulse oximeter
Time Frame	assessed from 2 min before to 5 min after injection (at 30-s intervals)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IANB/Inferior Alveolar Nerve Block	IANB+IO	IANB+PDL	IANB+BI
Arm/Group Description	patients were given a standard IANB with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain). local anesthesia: technique for local anesthesia	patients were given a standard IANB (1.8 ml) followed by an intra-osseous injection with 1.8 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain). local anesthesia: technique for local anesthesia	patients were given standard IANB (1.8 ml) followed by a PDL injection with 1.8 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain). local anesthesia: technique for local anesthesia	patients were given a standard IANB )1.8 ml) followed a Buccal Infiltration injection with 1.8 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain). local anesthesia: technique for local anesthesia
Measure Participants	40	40	40	40
-2 minutes	72 (4)	72 (5)	71 (4)	71 (5)
-1.5 minutes	71 (4)	72 (5)	70 (4)	69 (4)
-1 minute	71 (5)	71 (4)	71 (5)	70 (4)
-0.5 minute	72 (5)	72 (5)	72 (4)	71 (3)
0 minutes	75 (6)	80 (7)	74 (5)	72 (5)
0.5 minute	76 (4)	85 (5)	75 (6)	72 (4)
1 minute	74 (5)	84 (6)	73 (4)	71 (4)
1.5 minutes	74 (5)	83 (7)	73 (5)	71 (4)
2 minutes	72 (4)	80 (6)	72 (5)	71 (4)
2.5 minutes	72 (4)	77 (5)	72 (3)	70 (4)
3 minutes	71 (3)	74 (4)	72 (4)	71 (2)
3.5 minutes	72 (3)	72 (4)	72 (4)	71 (3)
4 minutes	72 (4)	71 (3)	71 (3)	72 (3)
4.5 minutes	71 (4)	72 (3)	71 (3)	71 (2)
5 minutes	71 (3)	71 (2)	71 (1)	72 (3)

Adverse Events

Time Frame	from 2 min before to 5 min after injection, at 30-s intervals.
Adverse Event Reporting Description	Only healthy individuals participated in the trial, so they were not liable to any adverse effect associated with the standard dental injections. Even no one complained from prolonged lip numbness.
Arm/Group Title	IANB/Inferior Alveolar Nerve Block		IANB+IO		IANB+PDL		IANB+BI
Arm/Group Description	patients will be given standard IANB with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain). local anesthesia: technique for local anesthesia		patients will be given standard IANB plus an intra-osseous with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain). local anesthesia: technique for local anesthesia		patients will be given standard IANB plus a PDL injection with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain). local anesthesia: technique for local anesthesia		patients will be given standard IANB plus a BI injection with 3.6 ml Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona, Spain). local anesthesia: technique for local anesthesia
All Cause Mortality
	IANB/Inferior Alveolar Nerve Block		IANB+IO		IANB+PDL		IANB+BI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)
Serious Adverse Events
	IANB/Inferior Alveolar Nerve Block		IANB+IO		IANB+PDL		IANB+BI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	IANB/Inferior Alveolar Nerve Block		IANB+IO		IANB+PDL		IANB+BI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)		0/40 (0%)		0/40 (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.