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: A Randomized Clinical Trial

NCT07506265 | Completed Phase 4 DMC

• 1 other identifier: RECO6U/34-2024
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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 will compare 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 will:

• Be intraligamentary injected by drugs or a placebo once prior to buccal infiltration anesthesia
• Report pain intensity using VAS at baseline (pre-injection), during access, and at 6, 24, 48 hours post-op (patient diary / phone follow-up).
• Report Onset time to subjective numbness (time from buccal infiltration to lip/tongue numbness).

Conditions

Irreversible Pulpitis (Toothache)

Keywords

dexamethasone, chymotrypsin, diclofenac sodium, local anesthesia, buccal infiltration, irrevesible pulpitis

Outcome Measures

Primary Outcomes (1)

• • Anesthetic success defined as no response to thermal test, electric pulp test and lip numbness and no pain (VAS ≤ 0 or no subjective pain/stimulation response) during endodontic access and initial instrumentation without need for additional local anes

  from anesthsesia administartion till 48 hours postoperative

Study Arms (2)

placebo

PLACEBO COMPARATOR

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

Drug: Dexamathsone 4mg/ml associated with experimental arm; Drug: Diclofenac Sodium (DCS); Drug: chymotrypsin

articaine

ACTIVE COMPARATOR

Drug: Dexamathsone 4mg/ml associated with experimental arm; Drug: Diclofenac Sodium (DCS); Drug: chymotrypsin

Interventions

Dexamathsone 4mg/ml associated with experimental arm DRUG

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

articaine; placebo

Diclofenac Sodium (DCS) DRUG

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

articaine; placebo

chymotrypsin DRUG

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

articaine; placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- irreversible pulpitis

You may not qualify if:

• patient above 50 years old

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Faculty of dentistry, Fayoum University

Al Fayyum, Egypt

Location

MeSH Terms

Conditions

Toothache

Interventions

Diclofenac; Chymotrypsin

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: May 23, 2025
• Primary Completion: December 29, 2025
• Study Completion: January 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

EG (1)