From Tooth to Bone: Can Mineralized Dentin Graft Be a Viable Alternative to Beta-Tricalcium Phosphate for Alveolar Ridge Preservation? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in Alveolar Bone Width From Baseline to 6 Months
研究概览
简要总结
The goal of this clinical trial was to compare three ways of helping the jawbone heal after removal of a tooth. The jawbone that supports a tooth is called the alveolar ridge. This bone can become narrower after a tooth is removed.
Participants were randomly assigned to one of three groups. One group received no bone graft material. One group received mineralized dentin graft made from the participant's extracted tooth. One group received beta-tricalcium phosphate, which is a synthetic bone graft material.
Participants had cone-beam computed tomography, a three-dimensional dental X-ray, immediately after tooth removal and again after 6 months. During dental implant placement at 6 months, researchers collected a small bone sample to examine healing.
详细描述
After tooth extraction, the alveolar ridge undergoes natural remodeling that can reduce its width and affect future dental implant placement. Alveolar ridge preservation aims to limit these dimensional changes. This randomized controlled clinical trial compared autogenous mineralized dentin graft, beta-tricalcium phosphate, and healing without bone graft material following extraction of hopeless maxillary teeth.
Participants were randomly assigned in a 1:1:1 ratio to three groups. The control group received no bone graft material. The mineralized dentin graft group received graft particles prepared from the participant's extracted tooth. The beta-tricalcium phosphate group received a synthetic bone graft material.
Alveolar ridge width was measured using cone-beam computed tomography immediately after extraction and at 6 months.
During delayed dental implant placement at 6 months, a small bone-core sample was collected from each study site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and the radiographic and histomorphometric outcome assessors were masked to group assignment. The statistician was also masked. The operating surgeon could not be masked and learned the group assignment after tooth extraction when the sealed allocation envelope was opened.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older.
- •Clinical indication for extraction of a hopeless maxillary tooth.
- •No evidence of acute infection at the intended extraction site.
- •Willing and able to comply with the scheduled study visits and follow-up procedures.
- •Provided written informed consent.
排除标准
- •Systemic disorder known to impair bone metabolism.
- •History of radiotherapy involving the head and neck region.
- •Pregnancy or lactation.
- •Advanced periodontal disease.
研究组 & 干预措施
Autogenous Mineralized Dentin Graft
Following atraumatic tooth extraction, autogenous mineralized dentin graft prepared chairside from the participant's extracted tooth is placed in the extraction socket.
干预措施: Alveolar Ridge Preservation With Autogenous Mineralized Dentin Graft (Procedure)
Beta-Tricalcium Phosphate
Following atraumatic tooth extraction, beta-tricalcium phosphate granules are placed in the extraction socket.
干预措施: Alveolar Ridge Preservation With Beta-Tricalcium Phosphate (Procedure)
Control: No Bone Graft
Following atraumatic tooth extraction, no bone graft material is placed in the extraction socket.
干预措施: Extraction Socket Healing Without Bone Graft (Procedure)
结局指标
主要结局
Change in Alveolar Bone Width From Baseline to 6 Months
时间窗: Baseline immediately after tooth extraction and 6 months
Alveolar bone width was measured in millimeters using cone-beam computed tomography immediately after tooth extraction and at 6 months. Width was measured horizontally from the outer buccal cortical surface to the palatal cortical surface.
次要结局
未报告次要终点
研究者
Soaad Tolba Mohammed Tolba Badawi
Lecturer of Oral and Maxillofacial Surgery
Mansoura University