Enamel Matrix Derivative and Xenograft for Mandibular Molar Furcation Defects
Efficacy of Enamel Matrix Derivative Combined With Xenograft in the Treatment of Furcation Defects in Mandibular Molars
This randomized controlled clinical trial aims to compare two regenerative surgical approaches for the treatment of mandibular molar Class II furcation defects in patients with periodontitis. Eligible furcation defects will be randomly assigned to receive either xenograft bone combined with enamel matrix derivative (EMD) or xenograft bone combined with a collagen membrane. Both approaches are used to support periodontal tissue regeneration.
Participants will be followed for approximately 7 months. The study will evaluate postoperative pain and patient-reported satisfaction, periodontal clinical parameters, changes in furcation defect volume and relative bone density on cone-beam computed tomography (CBCT), and changes in gingival crevicular fluid TWEAK levels. Clinical and radiographic outcomes will be assessed before surgery and during follow-up, including at 3 and 6 months after surgery.
The study is intended to determine whether xenograft bone combined with EMD provides clinical, radiographic, biological, and patient-reported outcomes comparable or superior to xenograft bone combined with a collagen membrane in the regenerative treatment of mandibular molar Class II furcation defects.
調査の概要
状態
詳細な説明
This is a randomized controlled clinical trial involving patients with periodontitis who have Class II furcation defects affecting mandibular first and/or second molars. A total of 24 eligible teeth are planned, with 12 teeth assigned to each treatment group.
Before surgery, participants will undergo clinical periodontal examination, intraoral three-dimensional scanning, CBCT imaging, and gingival crevicular fluid collection. Clinical measurements include plaque index (PI), gingival index (GI), probing pocket depth (PPD), vertical clinical attachment loss (VCAL), and horizontal clinical attachment loss (HCAL).
Eligible defects will be randomly assigned to one of two regenerative surgical treatments. Following flap elevation, debridement, root surface cleaning, and conditioning with 24% EDTA, the control group will receive xenograft bone covered with a resorbable collagen membrane. The experimental group will receive enamel matrix derivative applied to the defect-related root surface, followed by xenograft bone combined with enamel matrix derivative. The flap will then be repositioned and sutured.
Postoperative pain will be assessed using a visual analog scale, together with analgesic consumption and patient-reported satisfaction regarding swelling and chewing ability. Participants will return for follow-up at approximately 2 weeks, 1 month, 3 months, and 6 months after surgery. Gingival crevicular fluid will be collected during follow-up for measurement of TWEAK concentration.
At 3 months, selected periodontal and biological assessments will be repeated. At 6 months, periodontal clinical measurements, intraoral three-dimensional scanning, furcation defect classification, and CBCT imaging will be repeated to evaluate changes in defect volume and relative bone density.
The primary purpose of the study is to compare the regenerative effectiveness of xenograft bone combined with enamel matrix derivative with that of xenograft bone combined with a collagen membrane for the treatment of mandibular molar Class II furcation defects.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Binh Phu
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Ho Chi Minh City、Binh Phu、ベトナム、700000
- 募集
- Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
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コンタクト：
- Tuong Vy T Huynh
- 電話番号：+84 765 414 119
- メール：htrtuongvy@gmail.com
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参加基準
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
説明
Inclusion Criteria:
- Age 18 years or older.
- Full-mouth plaque score (FMPS) ≤ 20%.
- Full-mouth bleeding score (FMBS) ≤ 20%.
- Willingness to participate in the study and provide informed consent.
- Mandibular first and/or second molar with a buccal Class II furcation defect classified as subgroup A2 or B2.
- Probing pocket depth (PPD) ≥ 5 mm at the eligible furcation site.
- Keratinized gingival height ≥ 2 mm at the eligible site.
- No gingival recession extending apically beyond the buccal furcation roof; the furcation entrance must not be clinically exposed above the gingival margin.
Exclusion Criteria:
- Systemic diseases or conditions that may affect periodontal treatment outcomes, including uncontrolled diabetes mellitus, heart disease requiring anticoagulant therapy, hematologic disorders, or immunodeficiency.
- Pregnancy or breastfeeding.
- Untreated endodontic pathology involving the study tooth.
- Class III furcation involvement according to the Hamp classification.
- Untreated occlusal trauma involving the study tooth.
- Grade II tooth mobility that has not been stabilized by splinting, or Grade III tooth mobility according to the Miller classification.
- Defective restorations at the surgical site, including overhanging, bulky, or poorly adapted restorations.
研究計画
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 |
|---|---|
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実験的：Xenograft + Enamel Matrix Derivative
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Periodontal regenerative surgery is performed using xenograft bone combined with enamel matrix derivative (EMD).
After flap elevation, thorough defect debridement, and root surface conditioning with 24% EDTA for 2 minutes, EMD is applied to the root surface associated with the furcation defect.
The xenograft bone is mixed with EMD and placed to completely fill the defect.
The flap is then repositioned and sutured.
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アクティブコンパレータ：Xenograft + Collagen Membrane
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Periodontal regenerative surgery is performed using xenograft bone combined with a resorbable collagen membrane.
After flap elevation, thorough defect debridement, and root surface conditioning with 24% EDTA for 2 minutes, the xenograft bone is mixed with sterile saline and placed to completely fill the furcation defect.
A trimmed resorbable collagen membrane is positioned to completely cover the defect and secured before flap repositioning and suturing.
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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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Change in Probing Pocket Depth (PPD)
時間枠：Baseline and 6 months after surgery
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Probing pocket depth (PPD) is measured in millimeters from the gingival margin to the base of the periodontal pocket using a UNC-15 periodontal probe at the mesiobuccal, buccal, and distobuccal sites of the treated tooth.
Measurements are standardized using an individualized acrylic stent.
The change in PPD from baseline to 6 months after surgery will be compared between the two treatment groups.
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Baseline and 6 months after surgery
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Change in Horizontal Clinical Attachment Loss (HCAL)
時間枠：Baseline and 6 months after surgery
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Horizontal clinical attachment loss (HCAL) is measured in millimeters from the buccal entrance of the furcation to the deepest horizontal point of the furcation defect using a Nabers periodontal probe and an individualized acrylic stent.
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Baseline and 6 months after surgery
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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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Change in Vertical Clinical Attachment Loss (VCAL)
時間枠：Baseline and 6 months after surgery
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Baseline and 6 months after surgery
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Change in Buccal Gingival Recession (REC)
時間枠：Baseline, 3 months, and 6 months after surgery
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Baseline, 3 months, and 6 months after surgery
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Change in Plaque Index (PI)
時間枠：Baseline, 3 months, and 6 months after surgery
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Baseline, 3 months, and 6 months after surgery
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Change in Gingival Index (GI)
時間枠：Baseline and 6 months after surgery
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Baseline and 6 months after surgery
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Change in Furcation Defect Volume on CBCT
時間枠：Baseline and 6 months after surgery
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Baseline and 6 months after surgery
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Change in Relative Bone Density on CBCT
時間枠：Baseline and 6 months after surgery
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Baseline and 6 months after surgery
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Change in Gingival Crevicular Fluid TWEAK Concentration
時間枠：Baseline, 1 month, and 3 months after surgery
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Baseline, 1 month, and 3 months after surgery
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Postoperative Pain Assessed by Visual Analog Scale (VAS)
時間枠：12 hours, 24 hours, and 72 hours after surgery
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12 hours, 24 hours, and 72 hours after surgery
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Postoperative Analgesic Consumption
時間枠：During the first 3 days after surgery
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During the first 3 days after surgery
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Patient Satisfaction With Postoperative Swelling
時間枠：3 and 7 days after surgery
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Patient-reported satisfaction with postoperative swelling will be assessed using a 5-point Likert scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied.
Higher scores indicate better satisfaction (better outcome).
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3 and 7 days after surgery
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Patient Satisfaction With Chewing Ability
時間枠：3 and 7 days after surgery
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Patient-reported satisfaction with chewing ability after surgery will be assessed using a 5-point Likert scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied.
Higher scores indicate better satisfaction (better outcome).
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3 and 7 days after surgery
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 26412-ĐHYD
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