MMP-2/3 and Periapical Healing Outcomes

NCT07529964 | Not Yet Recruiting

• 1 other identifier: 3
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Apical Periodontitis; Periapical Healing

Outcome Measures

Primary Outcomes (1)

• Radiographic Periapical Healing

  The primary outcome will be radiographic healing assessed using the Periapical Index (PAI) scoring system on standardized periapical radiographs.

  12 months after treatment

Secondary Outcomes (1)

• Association Between MMP Genotypes and Healing Outcomes

  Baseline (genotyping) and 12 months after treatment

Study Arms (1)

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

Interventions

Nonsurgical Root Canal Treatment PROCEDURE

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.

Standardized Root Canal Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Single-rooted teeth
• PAI score ≥ 3
• Fully developed root apices
• Periodontal probing depth less than 5 mm
• Indication for primary nonsurgical root canal treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 14, 2026
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): May 25, 2027
• Study Completion (Estimated): June 25, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share