Postoperative Pain
Conditions
Keywords
Endodontics Genetic Polymorphism NSAIDs Preoperative Analgesia Pain Sensitivity
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.
Interventions
DRUGIbuprofen 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.
DRUGdiclofenac 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.
DRUGPlacebo
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.
Sponsors
Ataturk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactErtugrul Karatas, Prof. Dr.
Backup ContactMelike Kahramanlar, Postgraduate Student
Outcome results
None listed