The MTA Effect on Healing and Biomarkers in Endo-Perio Lesions
2026年6月13日 更新者：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.
調査の概要
状態
完了
詳細な説明
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.
研究の種類
介入
入学 (実際)
120
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Istanbul、トルコ（Türkiye）
- Istanbul Medipol University, Faculty of Dentistry, Department of Endodontics
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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アクティブコンパレータ：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).
|
|
実験的：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.
|
|
アクティブコンパレータ：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).
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Periapical Index (PAI) Score
時間枠：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)
時間枠：Baseline and 1 year
|
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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in TNF-α Concentration in Gingival Crevicular Fluid
時間枠：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
時間枠：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.
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Baseline and 1 year
|
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Change in MMP-8 Concentration in Gingival Crevicular Fluid
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：yelda erdem hepsenoglu, Assoc.Prof.、Istanbul Medipol University, Faculty of Dentistry, Department of Endodontics
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年3月20日
一次修了 (実際)
2025年4月10日
研究の完了 (実際)
2026年4月20日
試験登録日
最初に提出
2026年5月6日
QC基準を満たした最初の提出物
2026年6月13日
最初の投稿 (実際)
2026年6月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月17日
QC基準を満たした最後の更新が送信されました
2026年6月13日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 10840098-202.3.02-E.1144
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
De-identified individual participant data underlying the published results will be made available upon reasonable request following publication of the primary study results.
IPD 共有時間枠
Beginning after publication of the primary study results.
IPD 共有アクセス基準
Access will be provided to qualified researchers upon reasonable request and approval by the study investigators.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
はい
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。