drugset / Trial / NCT07506265

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

Phase 4 Completed 105 enrolled Fayoum University
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Chymotrypsin Protein / enzyme biologic Other
Comparator Dexamethasone Small molecule 4 mg/ml Other
Comparator Diclofenac Other / unclassified Other

Indications