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Autologous Demineralized Dentin Graft With or Without Melatonin for Immediate Implant Osseointegration

2026년 5월 20일 업데이트: Abd El Fattah ELSaid Attia Mowafy, Suez Canal University

Effect of Autologous Demineralized Dentin Graft With or Without Melatonin Gel on the Osseo Integration of Immediately Placed Implants: A Randomized Clinical Study

This randomized clinical study aims to evaluate the effect of autologous demineralized dentin graft (ADDG) with or without melatonin gel on the osseointegration of immediately placed dental implants in the maxillary premolar region. Sixteen patients requiring extraction and immediate implant placement will be randomly allocated into two groups. Clinical and radiographic outcomes including implant stability, peri-implant probing depth, modified bleeding index, marginal bone loss, buccal bone thickness, and bone density will be evaluated over a 9-month follow-up period.

연구 개요

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

중재적

등록 (추정된)

16

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

      • Ismailia, 이집트
        • 모병
        • Suez Canal University, Faculty of Dentistry
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

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

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

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
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.
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.
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.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Implant Stability Quotient (ISQ)
기간: Baseline and 6 months
Measured using Penguin device immediately after implant placement and after 6 months.
Baseline and 6 months
Jumping Distance
기간: Immediate postoperative and 9 months after implant placement
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.
Immediate postoperative and 9 months after implant placement
Marginal Bone Loss
기간: Immediate postoperative and 9 months after implant placement
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.
Immediate postoperative and 9 months after implant placement
Bone Density
기간: Immediate postoperative and 9 months after implant placement
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.
Immediate postoperative and 9 months after implant placement

2차 결과 측정

결과 측정
측정값 설명
기간
Buccal Bone Thickness (BBT)
기간: Preoperative, immediate postoperative, and 9 months after implant placement
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.
Preoperative, immediate postoperative, and 9 months after implant placement
Buccal Bone Height (BBH)
기간: Preoperative, immediate postoperative, and 9 months after implant placement
Buccal bone height will be assessed radiographically using CBCT as the vertical distance from the implant shoulder to the most coronal buccal bone point.
Preoperative, immediate postoperative, and 9 months after implant placement
Peri-Implant Sulcus Depth (PISD)
기간: Baseline, 6 months, and 9 months
Peri-implant sulcus depth will be measured clinically using a periodontal probe at the buccal, palatal, mesial, and distal aspects around the implant.
Baseline, 6 months, and 9 months
Modified Bleeding on Probing Index (MBOP)
기간: Baseline, 6 months, and 9 months
Modified bleeding on probing index will be recorded clinically using a periodontal probe to evaluate peri-implant soft tissue inflammation around the implant.
Baseline, 6 months, and 9 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

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

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 8월 11일

기본 완료 (추정된)

2026년 10월 10일

연구 완료 (추정된)

2026년 11월 10일

연구 등록 날짜

최초 제출

2026년 5월 20일

QC 기준을 충족하는 최초 제출

2026년 5월 20일

처음 게시됨 (실제)

2026년 5월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 20일

마지막으로 확인됨

2026년 5월 1일

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