The MTA Effect on Healing and Biomarkers in Endo-Perio Lesions
13. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
120
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
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Istanbul, Tyrkia (Türkiye)
- Istanbul Medipol University, Faculty of Dentistry, Department of Endodontics
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Endo-Perio + MTA
Teeth with combined endodontic-periodontal lesions treated with MTA apical plug and root canal therapy.
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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.
|
|
Aktiv komparator: Endo-Perio + Resin Sealer
Teeth with combined endo-perio lesions treated with resin-based root canal sealer (AH Plus).
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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).
|
|
Eksperimentell: 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.
|
|
Aktiv 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).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Periapical Index (PAI) Score
Tidsramme: Baseline and 1 year
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Periapical healing will be evaluated using the Periapical Index (PAI) score on periapical radiographs obtained at baseline and 1 year after treatment.
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Baseline and 1 year
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Change in Probing Depth (PD)
Tidsramme: Baseline and 1 year
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Periodontal healing will be assessed by measuring probing depth (PD) in millimeters at baseline and 1 year after treatment.
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Baseline and 1 year
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Change in Clinical Attachment Level (CAL)
Tidsramme: Baseline and 1 year
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Periodontal healing will be assessed by measuring clinical attachment level (CAL) in millimeters at baseline and 1 year after treatment.
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Baseline and 1 year
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in TNF-α Concentration in Gingival Crevicular Fluid
Tidsramme: Baseline and 1 year
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TNF-α concentration will be quantified by ELISA in gingival crevicular fluid samples collected at baseline and 1 year after treatment.
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Baseline and 1 year
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Change in IL-10 Concentration in Gingival Crevicular Fluid
Tidsramme: Baseline and 1 year
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IL-10 concentration will be quantified by ELISA in gingival crevicular fluid samples collected at baseline and 1 year after treatment.
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Baseline and 1 year
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Change in MMP-8 Concentration in Gingival Crevicular Fluid
Tidsramme: Baseline and 1 year
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MMP-8 concentration will be quantified by ELISA in gingival crevicular fluid samples collected at baseline and 1 year after treatment.
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Baseline and 1 year
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: yelda erdem hepsenoglu, Assoc.Prof., Istanbul Medipol University, Faculty of Dentistry, Department of Endodontics
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
20. mars 2024
Primær fullføring (Faktiske)
10. april 2025
Studiet fullført (Faktiske)
20. april 2026
Datoer for studieregistrering
Først innsendt
6. mai 2026
Først innsendt som oppfylte QC-kriteriene
13. juni 2026
Først lagt ut (Faktiske)
17. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. juni 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Periodontale sykdommer
- Munnsykdommer
- Stomatognatiske sykdommer
- Kjevesykdommer
- Periodontitt
- Periapikal periodontitt
- Periapikale sykdommer
- Fordøyelsessystem og orale fysiologiske fenomener
- Tannbehandling
- Tannfysiologiske fenomener
- Tannskalering
- Tannprofylakse
- Periodontics
- Subgingival curettage
- Forebyggende tannbehandling
- Rothøvding
- Tann peeling
Andre studie-ID-numre
- 10840098-202.3.02-E.1144
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual participant data underlying the published results will be made available upon reasonable request following publication of the primary study results.
IPD-delingstidsramme
Beginning after publication of the primary study results.
Tilgangskriterier for IPD-deling
Access will be provided to qualified researchers upon reasonable request and approval by the study investigators.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Ja
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