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

NCT04929522 | Completed Results

• 1 other identifier: FDASU-REC IM061101
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Root Canal Infection

Keywords

intra-osseous injection; PDL injection; IANB

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Successful Injection Technique Assessed by Verbal Rating Scale (VRS)

  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).

  15 minutes from delivery of anesthesia

Secondary Outcomes (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)

Study Arms (4)

IANB/inferior alveolar nerve block

ACTIVE COMPARATOR

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

IANB+IO

ACTIVE COMPARATOR

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

IANB+PDL

ACTIVE COMPARATOR

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

IANB+BI

ACTIVE COMPARATOR

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

Interventions

local anesthesia PROCEDURE

technique for local anesthesia

IANB+BI; IANB+IO; IANB+PDL; IANB/inferior alveolar nerve block

Eligibility Criteria

• Age: 21 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Anesthesia, Local

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Director of Clinical Trials in Endodontics
• Organization: AinShams University

endohashem@gmail.com

+2022639083

Study Officials

• Ahmed Abdel Rahman Hashem

  Ain Shams University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study was a prospective, randomized, parallel, triple blinded, clinical trial.

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 18, 2021
• Study Start: January 1, 2021
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: October 7, 2021
• Results First Posted: October 7, 2021

Record last verified: 2021-10

Locations

EG (1)