Clinical trial NCT06937853: Effect of Genetic Polymorphisms on Response to Preoperative NSAIDs in Endodontic Postoperative Pain Management
Official title: The Effect of Genetic Polymorphisms on the Response to Preoperative Non-Steroidal Anti-Inflammatory Drugs in the Management of Endodontic Postoperative Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Keywords: Endodontics Genetic Polymorphism NSAIDs Preoperative Analgesia Pain Sensitivity
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study adopts a parallel assignment model in which participants are randomly allocated into three groups: diclofenac sodium, ibuprofen, or placebo. Each participant receives a single dose of the assigned medication prior to root canal treatment. The primary aim is to evaluate the effectiveness of preoperative NSAIDs in reducing postoperative endodontic pain.

Additionally, the study explores whether genetic variations in drug-metabolizing enzymes affect individual responses to these medications. By analyzing these genetic differences, the study aims to determine their potential influence on postoperative pain levels, ultimately contributing to more personalized pain management approaches in dental practice.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Postoperative pain intensity
timeFrame: 7 days after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University, Faculty of Dentistry, Department of Endodontics
Study officials:
affiliation: Ataturk University, Faculty of Dentistry, Department of Endodontics
name: Ertugrul Karatas, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.