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Comparative Evaluation of Diclofenac Sodium and Ibuprofen for Post-Endodontic Pain Management

NCT07565012 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-04

No results posted yet for this study

Summary

This randomized controlled trial aims to compare the effectiveness of Diclofenac sodium and Ibuprofen in reducing pain after root canal treatment. Post-endodontic pain is a common complication following treatment of irreversible pulpitis and may affect patient comfort and recovery. Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed to manage postoperative dental pain due to their anti-inflammatory and analgesic properties.

A total of 60 adult participants diagnosed with irreversible pulpitis involving a single first molar will undergo single-visit root canal therapy. Participants will be randomly assigned to receive either diclofenac sodium 50 mg or ibuprofen 400 mg immediately after treatment. Pain levels will be recorded using a Visual Analogue Scale (VAS) at 6, 12, 24, and 48 hours following treatment. The use of rescue analgesics will also be documented.

The study aims to determine which medication provides better pain relief and reduces the need for additional analgesics following endodontic treatment. Findings from this study may help guide clinicians in selecting the most effective medication for postoperative pain management in dental practice.

Conditions

  • Irreversible Pulpitis
  • Post-endodontic Pain
  • Root Canal Treatment

Interventions

DRUG

Ibuprofen

Participants assigned to this intervention will receive 400 mg oral ibuprofen immediately after completion of single-visit root canal treatment. Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) commonly used for postoperative pain management due to its analgesic and anti-inflammatory effects. Pain intensity will be monitored using the Visual Analogue Scale at 6, 12, 24, and 48 hours after treatment.

DRUG

Diclofenac sodium

Participants assigned to this intervention will receive 50 mg oral diclofenac sodium immediately after completion of single-visit root canal treatment. Diclofenac sodium is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory properties used for postoperative pain control. Pain intensity will be assessed using the Visual Analogue Scale at 6, 12, 24, and 48 hours following treatment.

Sponsors & Collaborators

  • Armed Forces Institute of Dentistry, Pakistan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-03-12
Completion
2026-03-25

Countries

  • Pakistan

Study Locations

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Entities

Drugs

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 NCT07565012 on ClinicalTrials.gov