The MTA Effect on Healing and Biomarkers in Endo-Perio Lesions
Effect of Root Canal Obturation With MTA on Periodontal Healing and Inflammatory Biomarkers in Combined Endo-Perio Lesions: A Randomized Controlled Clinical Trial
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2026
CompletedFirst Submitted
Initial submission to the registry
May 6, 2026
CompletedFirst Posted
Study publicly available on registry
June 17, 2026
CompletedJune 17, 2026
May 1, 2026
1.1 years
May 6, 2026
June 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
Baseline and 1 year
Change in Probing Depth (PD)
Periodontal healing will be assessed by measuring probing depth (PD) in millimeters at baseline and 1 year after treatment.
Baseline and 1 year
Change in Clinical Attachment Level (CAL)
Periodontal healing will be assessed by measuring clinical attachment level (CAL) in millimeters at baseline and 1 year after treatment.
Baseline and 1 year
Secondary Outcomes (3)
Change in TNF-α Concentration in Gingival Crevicular Fluid
Baseline and 1 year
Change in IL-10 Concentration in Gingival Crevicular Fluid
Baseline and 1 year
Change in MMP-8 Concentration in Gingival Crevicular Fluid
Baseline and 1 year
Study Arms (4)
Endo-Perio + MTA
EXPERIMENTALTeeth with combined endodontic-periodontal lesions treated with MTA apical plug and root canal therapy.
Endo-Perio + Resin Sealer
ACTIVE COMPARATORTeeth with combined endo-perio lesions treated with resin-based root canal sealer (AH Plus).
AP + MTA
EXPERIMENTALTeeth with apical periodontitis treated with MTA apical plug.
AP + Resin Sealer
ACTIVE COMPARATORTeeth with apical periodontitis treated with resin-based sealer (AH Plus).
Interventions
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.
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).
Non-surgical periodontal treatment including scaling and root planing performed following endodontic treatment in patients diagnosed with combined endodontic-periodontal lesions.
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul Medipol University, Faculty of Dentistry, Department of Endodontics
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
yelda erdem hepsenoglu, Assoc.Prof.
Istanbul Medipol University, Faculty of Dentistry, Department of Endodontics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof. Yelda Erdem Hepşenoğlu
Study Record Dates
First Submitted
May 6, 2026
First Posted
June 17, 2026
Study Start
March 20, 2024
Primary Completion
April 10, 2025
Study Completion
April 20, 2026
Last Updated
June 17, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Beginning after publication of the primary study results.
- Access Criteria
- Access will be provided to qualified researchers upon reasonable request and approval by the study investigators.
De-identified individual participant data underlying the published results will be made available upon reasonable request following publication of the primary study results.