The MTA Effect on Healing and Biomarkers in Endo-Perio Lesions
13. Juni 2026 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
120
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
-
Istanbul, Türkei (türkiye)
- Istanbul Medipol University, Faculty of Dentistry, Department of Endodontics
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Endo-Perio + MTA
Teeth with combined endodontic-periodontal lesions treated with MTA apical plug and root canal therapy.
|
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.
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.
|
|
Aktiver Komparator: Endo-Perio + Resin Sealer
Teeth with combined endo-perio lesions treated with resin-based root canal 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.
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).
|
|
Experimental: AP + MTA
Teeth with apical periodontitis treated 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.
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.
|
|
Aktiver Komparator: AP + Resin Sealer
Teeth with apical periodontitis treated with resin-based sealer (AH Plus).
|
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.
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).
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Periapical Index (PAI) Score
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in TNF-α Concentration in Gingival Crevicular Fluid
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: yelda erdem hepsenoglu, Assoc.Prof., Istanbul Medipol University, Faculty of Dentistry, Department of Endodontics
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
20. März 2024
Primärer Abschluss (Tatsächlich)
10. April 2025
Studienabschluss (Tatsächlich)
20. April 2026
Studienanmeldedaten
Zuerst eingereicht
6. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
13. Juni 2026
Zuerst gepostet (Tatsächlich)
17. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
17. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
13. Juni 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Parodontale Erkrankungen
- Mundkrankheiten
- Stomatognathe Erkrankungen
- Kiefererkrankungen
- Parodontitis
- Periapikale Parodontitis
- Periapikale Erkrankungen
- Verdauungssystem und orale physiologische Phänomene
- Zahnheilkunde
- Zahnärztliche physiologische Phänomene
- Zahnärztliche Skalierung
- Zahnprophylaxe
- Parodontie
- Subgingival Curettage
- Präventive Zahnmedizin
- Wurzelplanung
- Zahnpeeling
Andere Studien-ID-Nummern
- 10840098-202.3.02-E.1144
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
De-identified individual participant data underlying the published results will be made available upon reasonable request following publication of the primary study results.
IPD-Sharing-Zeitrahmen
Beginning after publication of the primary study results.
IPD-Sharing-Zugriffskriterien
Access will be provided to qualified researchers upon reasonable request and approval by the study investigators.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Ja
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Apikale Parodontitis
-
Dow University of Health SciencesRekrutierungTyp-2-Diabetes-MeSH:D003924 | Periodontitis MeSH:D010518 | Diabetische Nephropathien MeSH:D003928Pakistan