Clinical, Radiographic and Volumetric Evaluation of the Entire Papilla Preservation Technique With and Without Connective Tissue Graft in the Treatment of Periodontal Intraosseous Defects.
2026年7月28日 更新者：Medical University of Warsaw
This study is to assess the impact of implementing subepithelial connective tissue graft (SCTG) in the treatment of periodontal intrabony defects with Entire Papilla Preservation Technique (EPPT) on the clinical and radiographic results after 6 and 12 months.
調査の概要
状態
まだ募集していません
条件
詳細な説明
This randomized controlled clinical trial aims to evaluate the clinical, radiographic, and volumetric outcomes of periodontal regenerative treatment using the Entire Papilla Preservation Technique (EPPT) with or without the addition of a subepithelial connective tissue graft (SCTG) in the treatment of intrabony periodontal defects.
Patients will be randomly assigned to receive EPPT combined with enamel matrix derivative (EMD) either with or without SCTG. Clinical, radiographic, and digital volumetric parameters will be assessed at baseline, 6 months, and 12 months to evaluate treatment outcomes.
Exploratory analyses will be conducted to assess the relationship between selected genetic polymorphisms (NLRP2 and IL-1β) and clinical outcomes of periodontal regeneration, including clinical attachment level, probing pocket depth, and gingival recession.
研究の種類
介入
入学 (推定)
30
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。
研究連絡先
- 名前：Małgorzata Wyszyńska-Pomian
- 電話番号：+48 504006984
- メール：malgorzata.wyszynska@wum.edu.pl
研究連絡先のバックアップ
- 名前：Bartłomiej Górski
- 電話番号：+48221166431
- メール：bartlomiej.gorski@wum.edu.pl
研究場所
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Bialystok、ポーランド、15276
- Department of Integrated Dentistry, University of Białystok
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コンタクト：
- Anna Skurska
- メール：annaskurska@wp.pl
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Szczecin、ポーランド
- Department of Periodontology, Pomeranian Medical University Contact
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コンタクト：
- Monika Machoy
- メール：monika.machoy@pum.edu.pl
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Warsaw
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Warsaw、Warsaw、ポーランド、00-246
- Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
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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
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age ≥ 18 years,
- Good compliance and good oral hygiene
- Systemically healthy
- Isolated two intrabony defects of more than 3 mm depth, combined with more than 6 mm probing depth and attachment loss (stage III/IV periodontitis) and an intrabony radiographic defect depth (DD) ≥ 3 mm, as evaluated on a digital periapical radiograph
- The associated tooth should either maintain normal pulp vitality or should have undergone root canal therapy for at least 6 months before.
Exclusion Criteria:
- Full-mouth plaque score ≥ 20% (O'Leary et al 1972)
- Full-mouth bleeding score ≥ 20% (Cortellini et al 1995)
- Smoking
- Systemic diseases that would adversely influence wound healing
- Medications interfering with post-operative wound healing
- Pregnant and lactating females
- Previous periodontal surgery in the examined area
- III-degree mobility
- Furcation involvement
- Pulpal pathology or inadequate endodontic treatment
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Entire Papilla Preservation Technique (EPPT) + EMD
Participants receive periodontal regenerative surgery using the Entire Papilla Preservation Technique (EPPT) combined with enamel matrix derivative (EMD).
After flap elevation and defect debridement, root surface conditioning with EDTA is performed, followed by application of enamel matrix derivative and placement of bone substitute material as needed.
Flaps are repositioned and sutured for primary closure.
|
A microsurgical periodontal regenerative technique aimed at preserving the interdental papilla.
The procedure includes flap elevation, defect debridement, root surface conditioning, application of regenerative materials, and primary wound closure.
Application of EDTA gel to the root surface to remove the smear layer and enhance regenerative outcomes.
A biologically active material applied to the root surface after EDTA conditioning to promote periodontal regeneration.
A xenogeneic bone graft material used to support bone regeneration within the intrabony defect.
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実験的：Entire Papilla Preservation Technique (EPPT) + EMD+ SCTG
Participants receive periodontal regenerative surgery using the Entire Papilla Preservation Technique (EPPT) combined with enamel matrix derivative (EMD) and subepithelial connective tissue graft (SCTG).
After flap elevation and defect debridement, root surface conditioning with EDTA is performed, followed by application of enamel matrix derivative and placement of bone substitute material.
A subepithelial connective tissue graft is harvested and placed at the defect site prior to flap closure.
|
A microsurgical periodontal regenerative technique aimed at preserving the interdental papilla.
The procedure includes flap elevation, defect debridement, root surface conditioning, application of regenerative materials, and primary wound closure.
Application of EDTA gel to the root surface to remove the smear layer and enhance regenerative outcomes.
A biologically active material applied to the root surface after EDTA conditioning to promote periodontal regeneration.
A xenogeneic bone graft material used to support bone regeneration within the intrabony defect.
An autogenous connective tissue graft harvested from the palate and placed at the surgical site to enhance soft tissue thickness and stability.
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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 |
|---|---|---|
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Clinical Attachment Level gain (CAL, mm)
時間枠：6 months and 12 months
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Clinical Attachment Level (CAL) gain, measured in millimeters (mm), defined as the change from baseline in the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket, assessed using a calibrated periodontal probe.
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6 months and 12 months
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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 |
|---|---|---|
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Probing Pocket Depth (PPD, mm)
時間枠：Baseline, 6 months and 12 months
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Probing Pocket Depth (PPD), measured in millimeters (mm), defined as the distance from the gingival margin to the base of the periodontal pocket, assessed using a calibrated periodontal probe.
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Baseline, 6 months and 12 months
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Probing Pocket Depth reduction (PPD, mm)
時間枠：6 months and 12 months
|
Probing Pocket Depth (PPD) reduction, measured in millimeters (mm), defined as the change from baseline in the distance from the gingival margin to the base of the periodontal pocket, assessed using a calibrated periodontal probe.
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6 months and 12 months
|
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Clinical Attachment Level (CAL, mm)
時間枠：Baseline, 6 months, and 12 months
|
Clinical Attachment Level (CAL), measured in millimeters (mm), defined as the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket, assessed using a calibrated periodontal probe.
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Baseline, 6 months, and 12 months
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Gingival Recession (GR, mm)
時間枠：Baseline, 6 months and 12 months
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Gingival recession (GR), measured in millimeters (mm), defined as the distance from the cemento-enamel junction (CEJ) to the gingival margin, assessed using a calibrated periodontal probe.
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Baseline, 6 months and 12 months
|
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Keratinized Tissue Width (KTW, mm)
時間枠：Baseline, 6 months and 12 months
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Keratinized tissue width (KTW), measured in millimeters (mm), defined as the distance from the gingival margin to the mucogingival junction, assessed using a periodontal probe.
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Baseline, 6 months and 12 months
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Gingival Thickness (GT, mm)
時間枠：Baseline, 6 months and 12 months
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Gingival thickness (GT), measured in millimeters (mm) at the buccal aspect 3 mm apical to the gingival margin using a standardized transgingival probing method with an endodontic file and stopper.
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Baseline, 6 months and 12 months
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Soft Tissue Volumetric Change (mm³)
時間枠：6 months and 12 months
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Change from baseline in soft tissue volume, expressed in cubic millimeters (mm³), assessed by superimposition of digital intraoral scans (STL files) using dedicated software with standardized reference areas.
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6 months and 12 months
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Radiographic Linear Defect Fill (LDF, mm)
時間枠：6 months and 12 months
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Linear defect fill (LDF), measured in millimeters (mm), assessed from standardized periapical radiographs using reproducible reference points.
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6 months and 12 months
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Radiographic Percentage Defect Fill (%DF)
時間枠：6 months and 12 months
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Percentage defect fill (%DF), expressed as a percentage (%), calculated based on standardized measurements obtained from periapical radiographs using a reproducible measurement protocol to assess bone defect resolution.
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6 months and 12 months
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Early Wound Healing Score (EHS)
時間枠：1 week and 2 weeks
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Early wound healing will be assessed using the Early Wound Healing Score (EHS), a composite clinical index ranging from 0 to 10 based on re-epithelialization, hemostasis, and inflammation, with higher scores indicating better healing.
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1 week and 2 weeks
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Full-Mouth Plaque Score (FMPS, %)
時間枠：Baseline, 6 months, and 12 months
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Percentage of tooth surfaces with dental plaque, assessed using a standardized plaque index and expressed as a percentage (%).
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Baseline, 6 months, and 12 months
|
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Full-Mouth Bleeding Score (FMBS, %)
時間枠：Baseline, 6 months, and 12 months
|
Percentage of tooth surfaces with bleeding on probing, assessed using a standardized method and expressed as a percentage (%).
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Baseline, 6 months, and 12 months
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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
- スタディチェア：Bartłomiej Górski、Depatrment of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
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 (推定)
2026年8月1日
一次修了 (推定)
2027年9月30日
研究の完了 (推定)
2027年11月30日
試験登録日
最初に提出
2026年4月2日
QC基準を満たした最初の提出物
2026年7月28日
最初の投稿 (実際)
2026年7月30日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月30日
QC基準を満たした最後の更新が送信されました
2026年7月28日
最終確認日
2026年1月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- Perio.06
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米国FDA規制機器製品の研究
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米国で製造され、米国から輸出された製品。
いいえ
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