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Recruiting NCT06937853

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

No phase Interventional Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ibuprofen 600 mg, diclofenac sodium, Placebo.
Who it may be relevant to
Registry conditions: Postoperative Pain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.
  • 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.
  • 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.

Primary outcome measures

  • Postoperative pain intensity [Time frame: 7 days after treatment]

Eligibility criteria

Inclusion criteria

  • Patients aged between 18 and 65 years
  • Vital mandibular molar teeth diagnosed with symptomatic apical periodontitis
  • ASA physical status classification I or II
  • Preoperative VAS pain score greater than 50
  • No known genetic disorders (e.g., Down syndrome, congenital insensitivity to pain)

Exclusion criteria

  • Patients classified as ASA III or higher
  • Pregnant women or those suspected of being pregnant
  • Presence of root canal curvature greater than 25° (Schilder classification)
  • Patients with generalized periodontitis
  • Presence of periodontal pockets deeper than 3 mm in the affected tooth
  • History of systemic disease or known allergies
  • Patients with diagnosed psychiatric or psychological disorders
  • Presence of swelling, sinus tract, or preoperative tenderness on palpation
  • Patients with bruxism
  • Presence of resorption in the affected tooth
  • Use of analgesic or anti-inflammatory drugs within 12 hours prior to the procedure
  • Teeth with root fractures, ankylosis, or pathological mobility

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Ataturk University, Faculty of Dentistry, Department of Endodontics — Erzurum

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. PMID 31435267

Identifiers

NCT: NCT06937853 · B.30.2.ATA.0.01.00/297

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗