Trial Outcomes & Findings for Success Rate of 4 Injection Protocols for Mandibular First Molars With Symptomatic Irreversible Pulpitis (NCT NCT04929522)

Last Updated: 2021-10-07

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

160 participants

Primary outcome timeframe

15 minutes from delivery of anesthesia

Results posted on

2021-10-07

Participant Flow

Participant milestones

Participant milestones
Measure	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). local anesthesia: technique for local anesthesia	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). local anesthesia: technique for local anesthesia	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). local anesthesia: technique for local anesthesia	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). local anesthesia: technique for local anesthesia
Overall Study STARTED	40	40	40	40
Overall Study COMPLETED	40	40	40	40
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IANB/Inferior Alveolar Nerve Block n=40 Participants 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	IANB+IO n=40 Participants 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	IANB+PDL n=40 Participants 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	IANB+BI n=40 Participants 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 n=160 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=40 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants	0 Participants n=160 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=40 Participants	40 Participants n=40 Participants	40 Participants n=40 Participants	40 Participants n=40 Participants	160 Participants n=160 Participants
Age, Categorical >=65 years	0 Participants n=40 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants	0 Participants n=160 Participants
Sex: Female, Male Female	25 Participants n=40 Participants	28 Participants n=40 Participants	26 Participants n=40 Participants	23 Participants n=40 Participants	102 Participants n=160 Participants
Sex: Female, Male Male	15 Participants n=40 Participants	12 Participants n=40 Participants	14 Participants n=40 Participants	17 Participants n=40 Participants	58 Participants n=160 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Egypt	40 participants n=40 Participants	40 participants n=40 Participants	40 participants n=40 Participants	40 participants n=40 Participants	160 participants n=160 Participants

PRIMARY outcome

Timeframe: 15 minutes from delivery of anesthesia

Outcome measures

Outcome measures
Measure	IANB/Inferior Alveolar Nerve Block n=40 Participants 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	IANB+IO n=40 Participants 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	IANB+PDL n=40 Participants 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	IANB+BI n=40 Participants 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
Number of Participants With Successful Injection Technique Assessed by Verbal Rating Scale (VRS)	16 Participants	37 Participants	29 Participants	26 Participants

SECONDARY outcome

Timeframe: assessed from 2 min before to 5 min after injection (at 30-s intervals)

beat per minute measured by a finger pulse oximeter

Outcome measures

Adverse Events

IANB/Inferior Alveolar Nerve Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IANB+IO

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IANB+PDL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IANB+BI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Trials in Endodontics

AinShams University

Phone: +2022639083

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	IANB/Inferior Alveolar Nerve Block n=40 Participants 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	IANB+IO n=40 Participants 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	IANB+PDL n=40 Participants 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	IANB+BI n=40 Participants 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
Changes in the Heart Rate Before, During and After the Injection 4.5 minutes	71 beat per minutes Standard Deviation 4	72 beat per minutes Standard Deviation 3	71 beat per minutes Standard Deviation 3	71 beat per minutes Standard Deviation 2
Changes in the Heart Rate Before, During and After the Injection -2 minutes	72 beat per minutes Standard Deviation 4	72 beat per minutes Standard Deviation 5	71 beat per minutes Standard Deviation 4	71 beat per minutes Standard Deviation 5
Changes in the Heart Rate Before, During and After the Injection -1.5 minutes	71 beat per minutes Standard Deviation 4	72 beat per minutes Standard Deviation 5	70 beat per minutes Standard Deviation 4	69 beat per minutes Standard Deviation 4
Changes in the Heart Rate Before, During and After the Injection -1 minute	71 beat per minutes Standard Deviation 5	71 beat per minutes Standard Deviation 4	71 beat per minutes Standard Deviation 5	70 beat per minutes Standard Deviation 4
Changes in the Heart Rate Before, During and After the Injection -0.5 minute	72 beat per minutes Standard Deviation 5	72 beat per minutes Standard Deviation 5	72 beat per minutes Standard Deviation 4	71 beat per minutes Standard Deviation 3
Changes in the Heart Rate Before, During and After the Injection 0 minutes	75 beat per minutes Standard Deviation 6	80 beat per minutes Standard Deviation 7	74 beat per minutes Standard Deviation 5	72 beat per minutes Standard Deviation 5
Changes in the Heart Rate Before, During and After the Injection 0.5 minute	76 beat per minutes Standard Deviation 4	85 beat per minutes Standard Deviation 5	75 beat per minutes Standard Deviation 6	72 beat per minutes Standard Deviation 4
Changes in the Heart Rate Before, During and After the Injection 1 minute	74 beat per minutes Standard Deviation 5	84 beat per minutes Standard Deviation 6	73 beat per minutes Standard Deviation 4	71 beat per minutes Standard Deviation 4
Changes in the Heart Rate Before, During and After the Injection 1.5 minutes	74 beat per minutes Standard Deviation 5	83 beat per minutes Standard Deviation 7	73 beat per minutes Standard Deviation 5	71 beat per minutes Standard Deviation 4
Changes in the Heart Rate Before, During and After the Injection 2 minutes	72 beat per minutes Standard Deviation 4	80 beat per minutes Standard Deviation 6	72 beat per minutes Standard Deviation 5	71 beat per minutes Standard Deviation 4
Changes in the Heart Rate Before, During and After the Injection 2.5 minutes	72 beat per minutes Standard Deviation 4	77 beat per minutes Standard Deviation 5	72 beat per minutes Standard Deviation 3	70 beat per minutes Standard Deviation 4
Changes in the Heart Rate Before, During and After the Injection 3 minutes	71 beat per minutes Standard Deviation 3	74 beat per minutes Standard Deviation 4	72 beat per minutes Standard Deviation 4	71 beat per minutes Standard Deviation 2
Changes in the Heart Rate Before, During and After the Injection 3.5 minutes	72 beat per minutes Standard Deviation 3	72 beat per minutes Standard Deviation 4	72 beat per minutes Standard Deviation 4	71 beat per minutes Standard Deviation 3
Changes in the Heart Rate Before, During and After the Injection 4 minutes	72 beat per minutes Standard Deviation 4	71 beat per minutes Standard Deviation 3	71 beat per minutes Standard Deviation 3	72 beat per minutes Standard Deviation 3
Changes in the Heart Rate Before, During and After the Injection 5 minutes	71 beat per minutes Standard Deviation 3	71 beat per minutes Standard Deviation 2	71 beat per minutes Standard Deviation 1	72 beat per minutes Standard Deviation 3