- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07610876
Autologous Demineralized Dentin Graft With or Without Melatonin for Immediate Implant Osseointegration
Effect of Autologous Demineralized Dentin Graft With or Without Melatonin Gel on the Osseo Integration of Immediately Placed Implants: A Randomized Clinical Study
연구 개요
상태
상세 설명
Patients requiring extraction and immediate implant placement in the maxillary premolar region often present with peri-implant defects and jumping gaps that may compromise osseointegration and long-term implant success. Autogenous bone grafts are considered the gold standard for bone augmentation because of their osteogenic, osteoinductive, and osteoconductive properties; however, they are associated with donor-site morbidity, limited availability, and increased surgical time. Recently, autologous demineralized dentin graft (ADDG) derived from extracted teeth has been introduced as a promising alternative grafting material due to its chemical and histological similarity to alveolar bone.
Dentin and bone share a common embryologic origin and similar composition, including type I collagen and low crystalline hydroxyapatite. Demineralized dentin graft material has demonstrated favorable osteoconductive and osteoinductive properties and has been successfully used in guided bone regeneration and immediate implant procedures. In immediate implant placement, the extracted tooth may be processed and reused as graft material to fill the jumping gap around the implant.
Melatonin (N-acetyl-5-methoxytryptamine) is an antioxidant molecule that has demonstrated beneficial effects on bone metabolism and osseointegration. Melatonin reduces osteoclastic activity, promotes osteoblast differentiation, enhances bone formation, and decreases oxidative stress during healing. Previous studies have suggested that local application of melatonin around dental implants may improve early osseointegration and bone healing.
The purpose of this randomized clinical study is to evaluate clinically and radiographically the effect of using melatonin gel in conjunction with autologous demineralized dentin graft on the osseointegration of immediately placed implants.
Sixteen patients with non-restorable maxillary premolar teeth indicated for extraction and immediate implant placement will be recruited from the outpatient clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Suez Canal University. Eligible patients will be randomly allocated into two equal groups. In Group I, immediate implants will be placed and the jumping gap will be filled using autologous demineralized dentin graft alone. In Group II, immediate implants will be placed and the jumping gap will be filled using autologous demineralized dentin graft mixed with melatonin gel.
Clinical assessment will include implant stability measurement using the Penguin device, peri-implant sulcus depth, and modified bleeding on probing index. Radiographic evaluation will be performed using cone beam computed tomography (CBCT) to assess marginal bone loss, buccal bone thickness, buccal bone height, jumping distance, and bone density at baseline, immediately after implant placement, and during follow-up periods up to 9 months postoperatively.
The results of this study may help determine whether the addition of melatonin gel to autologous demineralized dentin graft improves osseointegration and peri-implant bone healing in immediate implant placement procedures.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: B.S.D Abd El Fattah ELSaid Attia
- 전화번호: +20100465932
- 이메일: PGS.230043@dent.suez.edu.eg
연구 장소
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Ismailia, 이집트
- 모병
- Suez Canal University, Faculty of Dentistry
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연락하다:
- Dean, Faculty of Dentistry, Suez Canal University
- 전화번호: (+2064) 3223007
- 이메일: President_office@suez.edu.eg
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age above 20 years
- Non-restorable maxillary premolar teeth
- Candidates for immediate implant placement
- Intact socket walls
- Jumping gap >2 mm
- Non-smokers or light smokers
- No acute infection
- Adequate bone for primary stability
Exclusion Criteria:
- Heavy smokers
- Bruxism or clenching
- Uncontrolled systemic disease
- Chemotherapy/radiotherapy
- Immunocompromised patients
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: ADDG Alone
Participants in this arm will receive immediate implant placement in the maxillary premolar region with jumping gap filling using autologous demineralized dentin graft (ADDG) alone after extraction of non-restorable teeth.
Clinical and radiographic evaluation will be performed during the follow-up period.
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Autologous demineralized dentin graft prepared from extracted non-restorable teeth will be used for filling the jumping gap around immediately placed dental implants.
Tooth preparation includes removal of restorations, caries, periodontal ligament, pulp tissue, calculus, and cementum, followed by grinding and demineralization using 2% nitric acid before graft placement.
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실험적: ADDG + Melatonin Gel
Participants in this arm will receive immediate implant placement in the maxillary premolar region with jumping gap filling using autologous demineralized dentin graft (ADDG) mixed with melatonin gel after extraction of non-restorable teeth.
Clinical and radiographic evaluation will be performed during the follow-up period.
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Melatonin gel will be mixed with autologous demineralized dentin graft and used for filling the jumping gap around immediately placed dental implants in the maxillary premolar region to enhance osseointegration and peri-implant bone healing.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Implant Stability Quotient (ISQ)
기간: Baseline and 6 months
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Measured using Penguin device immediately after implant placement and after 6 months.
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Baseline and 6 months
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Jumping Distance
기간: Immediate postoperative and 9 months after implant placement
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The horizontal bucco-implant gap (jumping distance) will be measured radiographically using CBCT at 0 mm, 2 mm, and 5 mm apical to the implant shoulder as the perpendicular distance from the implant surface to the inner buccal bone plate.
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Immediate postoperative and 9 months after implant placement
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Marginal Bone Loss
기간: Immediate postoperative and 9 months after implant placement
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Marginal bone loss will be assessed radiographically using cone beam computed tomography (CBCT) as the vertical distance from the implant platform to the alveolar crest around the implant.
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Immediate postoperative and 9 months after implant placement
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Bone Density
기간: Immediate postoperative and 9 months after implant placement
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Bone density around the implant will be measured radiographically using CBCT and expressed in Hounsfield units (HU) to evaluate peri-implant bone maturation and osseointegration.
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Immediate postoperative and 9 months after implant placement
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Buccal Bone Thickness (BBT)
기간: Preoperative, immediate postoperative, and 9 months after implant placement
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Buccal bone thickness will be measured radiographically using standardized CBCT scans at 0 mm, 2 mm, and 5 mm apical to the implant shoulder to evaluate horizontal buccal bone dimensional changes around immediately placed implants.
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Preoperative, immediate postoperative, and 9 months after implant placement
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Buccal Bone Height (BBH)
기간: Preoperative, immediate postoperative, and 9 months after implant placement
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Buccal bone height will be assessed radiographically using CBCT as the vertical distance from the implant shoulder to the most coronal buccal bone point.
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Preoperative, immediate postoperative, and 9 months after implant placement
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Peri-Implant Sulcus Depth (PISD)
기간: Baseline, 6 months, and 9 months
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Peri-implant sulcus depth will be measured clinically using a periodontal probe at the buccal, palatal, mesial, and distal aspects around the implant.
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Baseline, 6 months, and 9 months
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Modified Bleeding on Probing Index (MBOP)
기간: Baseline, 6 months, and 9 months
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Modified bleeding on probing index will be recorded clinically using a periodontal probe to evaluate peri-implant soft tissue inflammation around the implant.
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Baseline, 6 months, and 9 months
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공동 작업자 및 조사자
수사관
- 연구 의자: Hany Kamel Shalaby, Professor of Oral Medicine and Periodontology, Dean Faculty of Dentistry
- 연구 책임자: Shaima Mohammed Morsy, Assistant Professor of Oral Medicine and Periodontology
- 연구 책임자: Rasha El-Sayed Afifi, Lecturer of Oral Medicine and Periodontology
- 수석 연구원: Abd El Fattah ELSaid Attia, B.S.D, B.S.D
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
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