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

Ataturk University

Status: Enrolling

Conditions: Postoperative Pain

Treatments: Drug: Ibuprofen 600 mg; Drug: diclofenac sodium; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06937853

B.30.2.ATA.0.01.00/297

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 3 patient groups, including a placebo group

Ibuprofen Group

Experimental group

Description:

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.

Treatment:

Drug: Ibuprofen 600 mg

diclofenac sodium

Experimental group

Description:

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.

Treatment:

Drug: diclofenac sodium

placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo