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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endo-Perio + MTA | Experimental | Teeth with combined endodontic-periodontal lesions treated with MTA apical plug and root canal therapy. |
|
| Endo-Perio + Resin Sealer | Active Comparator | Teeth with combined endo-perio lesions treated with resin-based root canal sealer (AH Plus). |
|
| AP + MTA | Experimental | Teeth with apical periodontitis treated with MTA apical plug. |
|
| AP + Resin Sealer | Active Comparator | Teeth with apical periodontitis treated with resin-based sealer (AH Plus). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Root Canal Treatment with MTA Apical Plug | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in TNF-α Concentration in Gingival Crevicular Fluid | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| yelda erdem hepsenoglu, Assoc.Prof. | Istanbul Medipol University, Faculty of Dentistry, Department of Endodontics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Medipol University, Faculty of Dentistry, Department of Endodontics | Istanbul | Turkey (Türkiye) |
De-identified individual participant data underlying the published results will be made available upon reasonable request following publication of the primary study results.
Beginning after publication of the primary study results.
Access will be provided to qualified researchers upon reasonable request and approval by the study investigators.
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|
| 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 Sampling | Other | 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. |
|
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 | 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 |
| ID | Term |
|---|---|
| D010485 | Periapical Periodontitis |
| D010483 | Periapical Diseases |
| ID | Term |
|---|---|
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D010518 | Periodontitis |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |
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