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NCT Number: NCT07653997

The MTA Effect on Healing and Biomarkers in Endo-Perio Lesions

This project is a randomized controlled clinical study investigating the effect of Mineral Trioxide Aggregate (MTA) used as an apical plug in root canal obturation on periodontal healing and inflammatory biomarkers in teeth with combined endodontic-periodontal (endo-perio) lesions. The study compares MTA with resin-based sealers and evaluates clinical, radiographic, and biochemical outcomes, including levels of IL-10, TNF-α, and MMP-8 in gingival crevicular fluid. The ultimate goal is to determine which treatment approach improves healing and increases tooth survival in such complex lesions.

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Key information

Conditions

Endodontic-Periodontal Lesions Apical Periodontitis Jaw Diseases Mouth Diseases Periapical Disease Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University, Faculty of Dentistry, Department of Endodontics

Istanbul, Turkey (Türkiye)

About this study

This study includes 120 patients, divided into three groups: healthy controls, patients with combined endo-perio lesions, and patients with apical periodontitis only. Standardized root canal treatment will be performed under aseptic conditions. Teeth will be obturated using either MTA apical plug or resin-based sealer (AH Plus) following mechanical preparation and irrigation protocols.

Clinical and radiographic healing will be assessed using periapical index (PAI) scores, and gingival crevicular fluid (GCF) samples will be collected at baseline and during follow-up (up to 1 year) to analyze inflammatory biomarkers (IL-10, TNF-α, MMP-8). Periodontal treatment will be performed when required in combined lesion cases.

Inclusion criteria

include patients aged 18-60 years, systemically healthy individuals, presence of radiographic periapical lesions, ability to provide informed consent, and willingness to attend follow-up visits.

Exclusion criteria

include patients with severe systemic diseases (ASA III-VI) and teeth with advanced mobility (Miller Class ≥3).

Statistical analyses (t-test, Mann-Whitney U, Pearson and Spearman correlations) will be used to compare groups and evaluate relationships between healing outcomes and biomarker levels. The study aims to determine whether MTA provides superior biological and clinical outcomes compared to conventional sealers and to improve treatment strategies and prognosis assessment in endo-perio lesions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 18 and 60 years Systemically healthy individuals Presence of radiographically confirmed periapical lesion Diagnosis of apical periodontitis and/or combined endodontic-periodontal lesion Ability to understand and sign informed consent Willingness to attend follow-up visits

Exclusion criteria

  • Patients with severe systemic diseases (ASA III-VI) Teeth with advanced mobility (Miller Class III or higher) Patients unable to tolerate dental treatment procedures Patients unwilling to participate or attend follow-up visits

Treatment and study plan

Root Canal Treatment with MTA Apical Plug

Procedure

Standardized root canal treatment performed under aseptic conditions. Following chemomechanical preparation, an apical plug is created using Mineral Trioxide Aggregate (MTA), and the remaining canal is obturated with resin-based sealer and gutta-percha.

Root Canal Treatment with Resin-Based Sealer (AH Plus)

Procedure

Standardized root canal treatment performed under aseptic conditions. After chemomechanical preparation, the canal is obturated using gutta-percha in combination with an epoxy resin-based sealer (AH Plus).

Periodontal Therapy (Scaling and Root Planing)

Procedure

Non-surgical periodontal treatment including scaling and root planing performed following endodontic treatment in patients diagnosed with combined endodontic-periodontal lesions.

Gingival Crevicular Fluid Sampling

Other

Collection of gingival crevicular fluid samples at baseline and follow-up visits for the analysis of inflammatory biomarkers (IL-10, TNF-α, MMP-8) using ELISA.

Primary outcomes

  1. Change in Periapical Index (PAI) Score

    Time frame: Baseline and 1 year

    Periapical healing will be evaluated using the Periapical Index (PAI) score on periapical radiographs obtained at baseline and 1 year after treatment.

  2. Change in Probing Depth (PD)

    Time frame: Baseline and 1 year

    Periodontal healing will be assessed by measuring probing depth (PD) in millimeters at baseline and 1 year after treatment.

  3. Change in Clinical Attachment Level (CAL)

    Time frame: Baseline and 1 year

    Periodontal healing will be assessed by measuring clinical attachment level (CAL) in millimeters at baseline and 1 year after treatment.

Secondary outcomes

  1. Change in TNF-α Concentration in Gingival Crevicular Fluid

    Time frame: Baseline and 1 year

    TNF-α concentration will be quantified by ELISA in gingival crevicular fluid samples collected at baseline and 1 year after treatment.

  2. Change in IL-10 Concentration in Gingival Crevicular Fluid

    Time frame: Baseline and 1 year

    IL-10 concentration will be quantified by ELISA in gingival crevicular fluid samples collected at baseline and 1 year after treatment.

  3. Change in MMP-8 Concentration in Gingival Crevicular Fluid

    Time frame: Baseline and 1 year

    MMP-8 concentration will be quantified by ELISA in gingival crevicular fluid samples collected at baseline and 1 year after treatment.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

Effect of Root Canal Obturation With MTA on Periodontal Healing and Inflammatory Biomarkers in Combined Endo-Perio Lesions: A Randomized Controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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