Effect of Genetic Polymorphisms on Response to Preoperative NSAIDs in Endodontic Postoperative Pain Management

Not Applicable

Recruiting

• Conditions: Postoperative Pain
• Interventions: Drug: Ibuprofen 600 mg; Drug: diclofenac sodium; Drug: Placebo

• Registration Number: NCT06937853
• Lead Sponsor: Ataturk University

Brief Summary

This study aims to evaluate the influence of genetic polymorphisms on the effectiveness of preoperative non-steroidal anti-inflammatory drugs (NSAIDs) in managing postoperative pain following endodontic treatment. Participants will receive standard preoperative NSAIDs before undergoing root canal therapy, and their pain responses will be assessed. Genetic analysis will be performed to investigate possible associations between drug response and individual gene variations. The study seeks to improve personalized approaches in endodontic pain management.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-10
• Status Verified: 2025-04
• Study First Submitted: 2025-04-14
• Study First Submitted QC: 2025-04-14
• Study First Posted: 2025-04-22
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-05-10
• Study Completion: 2025-06-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Patients aged between 18 and 65 years
2. Vital mandibular molar teeth diagnosed with symptomatic apical periodontitis
3. ASA physical status classification I or II
4. Preoperative VAS pain score greater than 50
5. No known genetic disorders (e.g., Down syndrome, congenital insensitivity to pain)

Exclusion Criteria

1. Patients classified as ASA III or higher
2. Pregnant women or those suspected of being pregnant
3. Presence of root canal curvature greater than 25° (Schilder classification)
4. Patients with generalized periodontitis
5. Presence of periodontal pockets deeper than 3 mm in the affected tooth
6. History of systemic disease or known allergies
7. Patients with diagnosed psychiatric or psychological disorders
8. Presence of swelling, sinus tract, or preoperative tenderness on palpation
9. Patients with bruxism
10. Presence of resorption in the affected tooth
11. Use of analgesic or anti-inflammatory drugs within 12 hours prior to the procedure
12. Teeth with root fractures, ankylosis, or pathological mobility

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen Group	Ibuprofen 600 mg	Participants in this arm will receive a single oral dose of 600 mg ibuprofen prior to the endodontic procedure. This intervention is intended to evaluate the preemptive analgesic effect of ibuprofen in the control of postoperative endodontic pain.
diclofenac sodium	diclofenac sodium	Participants in this arm will receive a single oral dose of 100 mg diclofenac sodium prior to the endodontic procedure. This intervention is intended to assess the preemptive analgesic efficacy of diclofenac sodium in controlling postoperative endodontic pain.
placebo	Placebo	Participants in this arm will receive a single oral dose of a placebo tablet, identical in appearance to the active drugs, prior to the endodontic procedure. This group serves as a control to assess the true analgesic efficacy of the active interventions.

Primary Outcome Measures

Name	Time	Method
Postoperative pain intensity	7 days after treatment	Pain intensity will be evaluated using the Visual Analog Scale (VAS). The scale ranges from 0 mm (no pain) to 100 mm (worst imaginable pain). A higher score indicates a worse outcome (more severe pain).; Patients will be asked to mark their pain level at 6 hours, 12 hours, 24 hours, and on postoperative days 2 (48 hours), 3 (72 hours), 5, and 7 following endodontic treatment.; The mean VAS scores at each time point will be analyzed and compared between treatment groups.

Trial Locations

Locations (1)

Ataturk University, Faculty of Dentistry, Department of Endodontics; 🇹🇷 Erzurum, Turkey