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

NCT06937853 | Recruiting

• 1 other identifier: B.30.2.ATA.0.01.00/297
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Endodontics Genetic Polymorphism NSAIDs Preoperative Analgesia Pain Sensitivity

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity

  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.

  7 days after treatment

Study Arms (3)

Ibuprofen Group

EXPERIMENTAL

Participants in this arm will receive a single oral dose of 600 mg ibuprofen prior to the endodontic procedure. This intervention is intended to evaluate the preemptive analgesic effect of ibuprofen in the control of postoperative endodontic pain.

Drug: Ibuprofen 600 mg

diclofenac sodium

EXPERIMENTAL

Participants in this arm will receive a single oral dose of 100 mg diclofenac sodium prior to the endodontic procedure. This intervention is intended to assess the preemptive analgesic efficacy of diclofenac sodium in controlling postoperative endodontic pain.

Drug: diclofenac sodium

placebo

PLACEBO COMPARATOR

Participants in this arm will receive a single oral dose of a placebo tablet, identical in appearance to the active drugs, prior to the endodontic procedure. This group serves as a control to assess the true analgesic efficacy of the active interventions.

Drug: Placebo

Interventions

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.

Ibuprofen Group

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.

diclofenac sodium

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.

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University, Faculty of Dentistry, Department of Endodontics

Erzurum, Erzurum, 25100, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ibuprofen; Diclofenac

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Phenylacetates

Study Officials

• Ertugrul Karatas, Prof. Dr.

  Ataturk University, Faculty of Dentistry, Department of Endodontics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ertugrul Karatas, Prof. Dr.

CONTACT

+905337080730; dtertu@windowslive.com

Melike Kahramanlar, Postgraduate Student

CONTACT

+905357992872; kahramanlarmelike@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: May 10, 2024
• Primary Completion: July 10, 2025
• Study Completion: August 3, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)