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NCT Number: NCT06937853

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University, Faculty of Dentistry, Department of Endodontics

Erzurum, 25100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ertugrul Karatas, Prof. Dr.

CONTACT

[email protected]

+905337080730

Ertugrul Karatas, Prof. Dr.

PRINCIPAL_INVESTIGATOR

Melike Kahramanlar, Postgraduate Student

CONTACT

[email protected]

+905357992872

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen 600 mg

Drug

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

Drug

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

Drug

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 outcomes

  1. Postoperative pain intensity

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ertugrul Karatas, Prof. Dr.

CONTACT

[email protected]

+905337080730

Melike Kahramanlar, Postgraduate Student

CONTACT

[email protected]

+905357992872

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 22, 2025
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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