Postoperative PainNCT06937853
Effect of Genetic Polymorphisms on Response to Preoperative NSAIDs in Endodontic Postoperative Pain Management
A study testing Ibuprofen 600 mg and diclofenac sodium in people with Postoperative Pain, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ibuprofen 600 mg and diclofenac sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2024to 3 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ataturk University, Faculty of Dentistry, Department of Endodontics
Erzurum, Erzurum, 25100
Ertugrul Karatas, Prof. Dr., +905337080730, dtertu@windowslive.com
Melike Kahramanlar, Postgraduate Student, +905357992872, kahramanlarmelike@gmail.com
About this study
Official title: The Effect of Genetic Polymorphisms on the Response to Preoperative Non-Steroidal Anti-Inflammatory Drugs in the Management of Endodontic Postoperative Pain
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
- Being tested
- Ibuprofen 600 mg, diclofenac sodium, Placebo
- Keywords
- Endodontics Genetic Polymorphism NSAIDs Preoperative Analgesia Pain Sensitivity
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 600 mgDrug
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 sodiumDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start10 May 2024
- Primary completion10 Jul 2025 (estimated)
- Study completion3 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ertuğrul karataş, Ataturk University
- Investigators
- Ertugrul Karatas, Prof. Dr., Principal investigator, Ataturk University, Faculty of Dentistry, Department of Endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937853
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/297
- Status last verified
- Jul 2025
- First submitted
- 14 Apr 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31435267
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Genetic Polymorphisms on the Response to Preoperative Non-Steroidal Anti-Inflammatory Drugs in the Management of Endodontic Postoperative Pain
- ClinicalTrials.gov ID
- NCT06937853
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/297
- Conditions
- Postoperative Pain
- Keywords
- Endodontics Genetic Polymorphism NSAIDs Preoperative Analgesia Pain Sensitivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 10 Jul 2025 (estimated)
- Study completion
- 3 Aug 2025 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen Group | Experimental | Drug: Ibuprofen 600 mgParticipants 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. |
| diclofenac sodium | Experimental | Drug: diclofenac sodiumParticipants 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. |
| placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen 600 mgA 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 | Ibuprofen Group |
| diclofenac sodiumA 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 | diclofenac sodium |
| PlaceboA 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. | Drug | placebo |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Background: PubMed 31435267AlRahabi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ertugrul Karatas, Prof. Dr. principal investigator
Ataturk University, Faculty of Dentistry, Department of Endodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen 600 mg and diclofenac sodium in people with Postoperative Pain, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ertugrul Karatas, Prof. Dr. (+905337080730, dtertu@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity (time frame: 7 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06937853, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.