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

NCT06937853 · tracked via the Priya Life Science Turkey tracker

Sponsor

Ataturk University

Phase

Not applicable

Started

2024-05-10

Last updated

2025-07-11

Condition(s) studied

Postoperative Pain

Investigational drug(s) / intervention(s)

Ibuprofen 600 mg →diclofenac sodium →Placebo

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.

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: 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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Accepted

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

Primary outcome measure(s)

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 sites (1)

Facility	City	Region	Status
Ataturk University, Faculty of Dentistry, Department of Endodontics	Erzurum	Erzurum	Recruiting

More Ataturk University trials in Turkey

Minimally Invasive Non-Surgical Periodontal Treatment Starting soon

The Effect of Two Different Analgesic Techniques on Postoperative Recovery Quality Recruiting

The Effect of Diabetes Education Given With Video Animation on Metabolic Control, Self-Care Ability, and Attitudes Towards the Disease in Children With Type 1 Diabetes Enrolling by invitation

Bupivacaine-Lidocaine vs Bupivacaine for Ultrasound-Guided Popliteal Sciatic Nerve Block Recruiting

The Effect of Rapid Relaxation Exercise and Cold Application on Pain, Anxiety, and Satisfaction Before Chest Tube Removal Starting soon

Other trials for the same condition

SPSIP vs ESP Block for Analgesia After Rib Fracture Surgery Starting soon

FRONT Block for Quality of Recovery After Total Hip Arthroplasty Recruiting

S-TAP vs RSB in Midline Abdominal Incision Laparotomy Active, not recruiting

Comparison of TAP Block and Umbilical Paramedian Linea Semilunaris Block in Pediatric Laparoscopic Surgery Starting soon

Serratus Posterior Superior Intercostal Plane Block in Minimally Invasive Cardiac Surgery Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06937853 on ClinicalTrials.gov ↗ ← All trials in Turkey