Comparative Evaluation of Intraligamentary Injection of Dexamethasone, Diclofenac Sodium, and Chymotrypsin for Enhancing the Success of 4% Articaine Buccal Infiltration in Mandibular Molars With Symptomatic Irreversible Pulpitis

NCT07506265 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2026-04-06

No results posted yet for this study

Summary

The goal of this clinical trial is to compare anesthetic success rates of intraligamentary dexamethasone, diclofenac sodium, and chymotrypsin administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis. Do these drugs lower the number of times participants need to be administrated with more local anesthesia? Researchers compared intraligamentary dexamethasone, diclofenac sodium, and chymotrypsin to a placebo (a look-alike substance that contains no drug) to see if interventional drugs work to achieve successful anesthesia.

* Participants were intraligamentary injected by drugs or a placebo once prior to buccal infiltration anesthesia
* Participants reported pain intensity using VAS at baseline (pre-injection), during access, and at 6, 24, 48 hours post-operative (patient diary / phone follow-up).
* Participants reported the onset time to subjective numbness (time from buccal infiltration to lip/tongue numbness).

Conditions

  • Irreversible Pulpitis (Toothache)

Interventions

DRUG

Dexamathsone 4mg/ml associated with experimental arm

intraligamentary dexamethasone administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis

DRUG

Diclofenac Sodium (DCS)

intraligamentary diclofenac sodium administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis

DRUG

chymotrypsin

intraligamentary chymotrypsin administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis

Sponsors & Collaborators

  • Fayoum University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-23
Primary Completion
2025-12-29
Completion
2026-01-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07506265 on ClinicalTrials.gov