此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2026年8月24日 更新者: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. Thirty 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.

研究概览

详细说明

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.

Thirty 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 buccal bone thickness, crestal 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.

研究类型

介入性

注册 (估计的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Ismailia、埃及
        • 招聘中
        • Suez Canal University, Faculty of Dentistry
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
实验性的: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Implant Stability Quotient (ISQ)
大体时间:Baseline and 6 months
Measured using Penguin device immediately after implant placement and after 6 months.
Baseline and 6 months
Jumping Distance
大体时间: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
Bone Density
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Peri-Implant Sulcus Depth (PISD)
大体时间: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)
大体时间: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
Buccal Bone Thickness (BBT)
大体时间: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.
Immediate postoperative, and 9 months after implant placement
Crestal Bone Height (CBH)
大体时间:Baseline (immediately after implant placement) and 9-month follow-up
CBH was measured from the implant platform to the most coronal crestal bone at the mesial, distal, buccal, and palatal aspects using standardized CBCT images.
Baseline (immediately after implant placement) and 9-month follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Hany Kamel Shalaby、Professor of Oral Medicine and Periodontology, Dean Faculty of Dentistry
  • 研究主任:Shaima Mohammed Morsy、Assistant Professor of Oral Medicine and Periodontology
  • 研究主任:Rasha El-Sayed Afifi、Lecturer of Oral Medicine and Periodontology
  • 首席研究员:Abd El Fattah ELSaid Attia, B.S.D、B.S.D

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年8月11日

初级完成 (估计的)

2026年10月10日

研究完成 (估计的)

2026年11月10日

研究注册日期

首次提交

2026年5月20日

首先提交符合 QC 标准的

2026年5月20日

首次发布 (实际的)

2026年5月28日

研究记录更新

最后更新发布 (实际的)

2026年8月26日

上次提交的符合 QC 标准的更新

2026年8月24日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅