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

Istanbul Medipol University Hospital120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Interventions

Root Canal Treatment with MTA Apical PlugPROCEDURE

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 SamplingOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in Periapical Index (PAI) Score

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