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

NCT07565012 | Completed Phase 4 DMC

• 2 other identifiers: AFID-OPER-PEP-2025-01IRB Approval Number
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Endodontic Therapy; Post-Endodontic Pain; Diclofenac sodium; Non-Steroidal Anti-Inflammatory Drugs (NSAIDs); Visual Analogue Scale; Irreversible Pulpitis; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity Following Root Canal Treatment

  Postoperative pain intensity will be assessed using a 10-point Visual Analogue Scale (VAS) to compare the analgesic effectiveness of Diclofenac sodium and Ibuprofen following single-visit root canal treatment. Participants will record pain scores at predefined intervals after treatment.

  6, 12, 24, and 48 hours after completion of root canal treatment

Secondary Outcomes (1)

• Rescue Analgesic Consumption Following Root Canal Treatment

  Within 48 hours after completion of root canal treatment

Study Arms (2)

Ibuprofen Group

EXPERIMENTAL

Participants assigned to this arm will receive a single oral dose of 400 mg of Ibuprofen immediately after completion of single-visit root canal treatment. Pain intensity will be recorded using the Visual Analogue Scale at 6, 12, 24, and 48 hours post-treatment. Rescue analgesic intake will also be documented.

Drug: Ibuprofen

Diclofenac Sodium Group

EXPERIMENTAL

Participants assigned to this arm will receive a single oral dose of 50 mg of Diclofenac sodium immediately after completion of single-visit root canal treatment. Pain intensity will be recorded using the Visual Analogue Scale at 6, 12, 24, and 48 hours post-treatment. Rescue analgesic intake will also be documented.

Drug: Diclofenac sodium

Interventions

Ibuprofen DRUG

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.

Also known as: Ibuprofen 400 mg

Ibuprofen Group

Diclofenac sodium DRUG

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.

Diclofenac Sodium Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with Irreversible Pulpitis involving a single maxillary or mandibular first molar Age between 18 and 65 years Patients requiring single-visit root canal treatment Patients able to understand and record pain using Visual Analogue Scale (VAS) Systemically healthy individuals (ASA I-II) Willingness to participate and provide informed consent

You may not qualify if:

• Pregnant or lactating women Presence of periapical pathology on radiographic examination Patients with generalized periodontal disease affecting prognosis Use of analgesics or anti-inflammatory drugs within 6 hours prior to treatment Known allergy to Ibuprofen, Diclofenac sodium, or other NSAIDs Patients on medications affecting pain perception (e.g., opioids, antidepressants, anticonvulsants) History of drug abuse or substance dependence Non-vital pulp detected during access opening or instrumentation Inability to complete endodontic treatment in a single visit Failure to achieve proper bleeding response confirming diagnosis of irreversible pulpitis

Sponsors & Collaborators

• Armed Forces Institute of Dentistry, Pakistan: lead

Study Sites (1)

Armed Forces Institute of Dentistry

Rawalpindi, 46000, Pakistan

Location

MeSH Terms

Interventions

Ibuprofen; Diclofenac

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Phenylacetates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are unaware of the specific medication assigned after treatment, and pain outcome assessment is conducted using standardized self-reported Visual Analogue Scale recordings reviewed by blinded outcome assessors. Medication allocation is concealed using sequentially numbered opaque sealed envelopes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee

Model Details: Participants are randomly assigned to one of two parallel groups receiving either diclofenac sodium 50 mg or ibuprofen 400 mg following single-visit root canal treatment. Outcomes are compared between groups over a 48-hour postoperative period.

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: October 1, 2025
• Primary Completion: March 12, 2026
• Study Completion: March 25, 2026
• Last Updated: May 4, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)