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

The Effect of Genetic Polymorphisms on the Response to Preoperative Non-Steroidal Anti-Inflammatory Drugs in the Management of Endodontic Postoperative Pain

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Ibuprofen 600 mg; Drug: diclofenac sodium; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ertugrul Karatas, Prof. Dr.; Phone Number: +905337080730; Email: dtertu@windowslive.com
• Study Contact Backup: Name: Melike Kahramanlar, Postgraduate Student; Phone Number: +905357992872; Email: kahramanlarmelike@gmail.com

Study Locations

• Turkey
  • Erzurum, Turkey, 25100
    • Recruiting
    • Atatürk University, Faculty of Dentistry, Department of Endodontics
    • Contact: Ertugrul Karatas, Prof. Dr.; Phone Number: +905337080730; Email: dtertu@windowslive.com
    • Contact: Melike Kahramanlar, Postgraduate Student; Phone Number: +905357992872; Email: kahramanlarmelike@gmail.com
    • Principal Investigator: Ertugrul Karatas, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ibuprofen Group; 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.	Drug: Ibuprofen 600 mg; A single oral dose of 600 mg ibuprofen will be administered prior to the endodontic procedure to evaluate its preemptive analgesic effect on postoperative dental pain.
Experimental: 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.	Drug: diclofenac sodium; A single oral dose of 100 mg diclofenac sodium will be administered to participants in the Diclofenac Sodium Group prior to the endodontic procedure. This intervention is designed to assess the preemptive analgesic efficacy of diclofenac sodium in the control of postoperative dental pain.
Placebo Comparator: 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.	Drug: Placebo; A single oral dose of a placebo tablet, identical in appearance to the active drugs, will be administered to participants in the Placebo Group prior to the endodontic procedure. This group serves as the control to evaluate the true analgesic efficacy of the active interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain intensity	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.	7 days after treatment

Collaborators and Investigators

• Sponsor: Ataturk University
• Investigators: Principal Investigator: Ertugrul Karatas, Prof. Dr., Atatürk University, Faculty of Dentistry, Department of Endodontics

Publications and helpful links

General Publications

• AlRahabi MK. Predictors, prevention, and management of postoperative pain associated with nonsurgical root canal treatment: A systematic review. J Taibah Univ Med Sci. 2017 May 9;12(5):376-384. doi: 10.1016/j.jtumed.2017.03.004. eCollection 2017 Oct.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2024
• Primary Completion (Estimated): July 10, 2025
• Study Completion (Estimated): August 3, 2025

Study Registration Dates

• First Submitted: April 14, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Endodontics Genetic Polymorphism NSAIDs Preoperative Analgesia Pain Sensitivity
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Diclofenac; Ibuprofen
• Other Study ID Numbers: B.30.2.ATA.0.01.00/297

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No