- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07529964
MMP-2/3 and Periapical Healing Outcomes
April 8, 2026 updated by: Ayşe Tuğba Eminsoy Avcı, TC Erciyes University
Association of MMP-2 and MMP-3 Polymorphisms With 12-Month Radiographic Healing After Nonsurgical Root Canal Treatment in Chronic Apical Periodontitis: A Prospective Clinical Study
This prospective randomized clinical study will investigate the association between MMP-2 and MMP-3 gene polymorphisms and radiographic healing outcomes following nonsurgical root canal treatment in patients with chronic apical periodontitis.
A total of 50 patients will undergo standardized endodontic treatment and will be followed for 12 months.
Genotyping will be performed using baseline DNA samples, and periapical healing will be assessed using the Periapical Index (PAI).
The relationship between genetic variations and treatment outcomes will be analyzed to determine whether host-related genetic factors influence healing patterns after root canal therapy.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
50
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The study population will consist of adult patients aged 18-65 years diagnosed with chronic apical periodontitis in single-rooted teeth and requiring primary nonsurgical root canal treatment.
All participants will be classified as ASA I or II and will be recruited from patients referred to the Department of Endodontics.
Only individuals meeting the predefined inclusion and exclusion criteria will be enrolled.
Participants will undergo standardized treatment and follow-up under controlled clinical conditions.
Description
Inclusion Criteria:
- Single-rooted teeth
- PAI score ≥ 3
- Fully developed root apices
- Periodontal probing depth less than 5 mm
- Indication for primary nonsurgical root canal treatment
Exclusion Criteria:
- Previous endodontic treatment in the selected tooth
- Diagnosis of symptomatic apical abscess
- Presence of root fracture or internal/external resorption
- Use of systemic antibiotics within the previous 4 weeks
- Analgesic intake within 48 hours before treatment
- Ongoing immunosuppressive therapy
- Pregnancy or breastfeeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Standardized Root Canal Treatment
Participants will undergo standardized nonsurgical root canal treatment using a uniform clinical protocol.
Radiographic healing outcomes will be evaluated at 12 months, and results will be analyzed in relation to MMP-2 and MMP-3 gene polymorphisms.
|
All participants will undergo standardized nonsurgical root canal treatment performed under a uniform clinical protocol.
After local anesthesia and rubber dam isolation, working length will be determined electronically and radiographically.
Root canal preparation will be completed with rotary instrumentation up to size 30/.06,
accompanied by sodium hypochlorite irrigation, EDTA, and ultrasonic activation.
Canals will then be obturated in the same visit using gutta-percha and epoxy resin-based sealer with the warm vertical condensation technique.
Periapical healing outcomes at 12 months will be evaluated in relation to MMP-2 and MMP-3 genetic polymorphisms.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Radiographic Periapical Healing
Time Frame: 12 months after treatment
|
The primary outcome will be radiographic healing assessed using the Periapical Index (PAI) scoring system on standardized periapical radiographs.
|
12 months after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Association Between MMP Genotypes and Healing Outcomes
Time Frame: Baseline (genotyping) and 12 months after treatment
|
The association between MMP-2 (rs243865) and MMP-3 (rs3025058) genotypes and radiographic healing outcomes will be evaluated.
Genotype and allele distributions will be compared between healed and non-healed groups to determine the potential influence of genetic polymorphisms on periapical healing following root canal treatment.
|
Baseline (genotyping) and 12 months after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 15, 2026
Primary Completion (Estimated)
May 25, 2027
Study Completion (Estimated)
June 25, 2027
Study Registration Dates
First Submitted
April 8, 2026
First Submitted That Met QC Criteria
April 8, 2026
First Posted (Actual)
April 14, 2026
Study Record Updates
Last Update Posted (Actual)
April 14, 2026
Last Update Submitted That Met QC Criteria
April 8, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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