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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: Nonsurgical Root Canal Treatment
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TC Erciyes University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 25, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 25, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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