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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Binh Phu
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Ho Chi Minh City, Binh Phu, 베트남, 700000
- 모병
- Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
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연락하다:
- Tuong Vy T Huynh
- 전화번호: +84 765 414 119
- 이메일: htrtuongvy@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Probing Pocket Depth (PPD)
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Vertical Clinical Attachment Loss (VCAL)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 26412-ĐHYD
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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