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

13 juin 2026 mis à jour par: Yelda Erdem Hepşenoğlu, Istanbul Medipol University Hospital

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

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

120

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Turquie (Türkiye)
      • Istanbul, Turquie (Türkiye)
        • Istanbul Medipol University, Faculty of Dentistry, Department of Endodontics

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Oui

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Endo-Perio + MTA
Teeth with combined endodontic-periodontal lesions treated with MTA apical plug and root canal therapy.
Procédure: Root Canal Treatment with MTA Apical Plug
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.
Procédure: Periodontal Therapy (Scaling and Root Planing)
Non-surgical periodontal treatment including scaling and root planing performed following endodontic treatment in patients diagnosed with combined endodontic-periodontal lesions.
Autre: Gingival Crevicular Fluid Sampling
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.
Comparateur actif: Endo-Perio + Resin Sealer
Teeth with combined endo-perio lesions treated with resin-based root canal sealer (AH Plus).
Procédure: Periodontal Therapy (Scaling and Root Planing)
Non-surgical periodontal treatment including scaling and root planing performed following endodontic treatment in patients diagnosed with combined endodontic-periodontal lesions.
Autre: Gingival Crevicular Fluid Sampling
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.
Procédure: Root Canal Treatment with Resin-Based Sealer (AH Plus)
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).
Expérimental: AP + MTA
Teeth with apical periodontitis treated with MTA apical plug.
Procédure: Root Canal Treatment with MTA Apical Plug
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.
Autre: Gingival Crevicular Fluid Sampling
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.
Comparateur actif: AP + Resin Sealer
Teeth with apical periodontitis treated with resin-based sealer (AH Plus).
Autre: Gingival Crevicular Fluid Sampling
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.
Procédure: Root Canal Treatment with Resin-Based Sealer (AH Plus)
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).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Periapical Index (PAI) Score
Délai: 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.
Baseline and 1 year
Change in Probing Depth (PD)
Délai: Baseline and 1 year
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)
Délai: Baseline and 1 year
Periodontal healing will be assessed by measuring clinical attachment level (CAL) in millimeters at baseline and 1 year after treatment.
Baseline and 1 year

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in TNF-α Concentration in Gingival Crevicular Fluid
Délai: 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.
Baseline and 1 year
Change in IL-10 Concentration in Gingival Crevicular Fluid
Délai: 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.
Baseline and 1 year
Change in MMP-8 Concentration in Gingival Crevicular Fluid
Délai: 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.
Baseline and 1 year

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Istanbul Medipol University Hospital

Les enquêteurs

  • Chercheur principal: yelda erdem hepsenoglu, Assoc.Prof., Istanbul Medipol University, Faculty of Dentistry, Department of Endodontics

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

20 mars 2024

Achèvement primaire (Réel)

10 avril 2025

Achèvement de l'étude (Réel)

20 avril 2026

Dates d'inscription aux études

Première soumission

6 mai 2026

Première soumission répondant aux critères de contrôle qualité

13 juin 2026

Première publication (Réel)

17 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 juin 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 10840098-202.3.02-E.1144

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

De-identified individual participant data underlying the published results will be made available upon reasonable request following publication of the primary study results.

Délai de partage IPD

Beginning after publication of the primary study results.

Critères d'accès au partage IPD

Access will be provided to qualified researchers upon reasonable request and approval by the study investigators.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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