Early Dental Implant Installation in Regeneration Sites: a Prof of Concept Prospective Case Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Histomorphometric percentage of newly formed bone
研究概览
简要总结
This study will evaluate bone healing after tooth extraction and alveolar ridge preservation, a common procedure used to maintain the bone volume needed for future dental implant placement.
Participants will be adult patients who require tooth extraction, ridge preservation, and later implant-supported rehabilitation as part of their routine dental treatment. After the tooth is removed, the extraction socket will be treated with a bone graft material and covered with a membrane according to standard clinical procedures.
At the time of implant placement, a small cylindrical bone sample will be collected from the same site where the implant will be placed. This tissue would normally be removed during preparation of the implant site. Therefore, no additional surgical access or tissue removal will be performed solely for research purposes.
The collected samples will be analyzed under the microscope to evaluate the amount and characteristics of newly formed bone and remaining graft material. The study aims to better understand the quality of bone regeneration after alveolar ridge preservation and its suitability for implant placement.
详细描述
Alveolar ridge preservation is commonly performed after tooth extraction to reduce post-extraction dimensional changes and support future implant placement. Although this procedure is widely used in clinical practice, the histologic characteristics of the regenerated tissue may vary depending on the biomaterial used, the healing period, and patient-related factors. Histomorphometric analysis of bone core biopsies obtained at the time of implant placement provides direct information about newly formed bone, residual graft particles, and non-mineralized tissue within the regenerated ridge.
This clinical study will be conducted in adult patients requiring tooth extraction, alveolar ridge preservation, and subsequent implant-supported rehabilitation as part of their routine dental treatment. After tooth extraction, the socket will be treated using a guided bone regeneration approach according to standard clinical procedures. The treated site will be allowed to heal before implant placement.
At the time of implant placement, a cylindrical bone core biopsy will be obtained during preparation of the implant osteotomy. The biopsy will be collected from tissue that would otherwise be removed as part of the standard implant site preparation. No additional surgical access or tissue removal will be performed exclusively for research purposes beyond collection of the trephine core from the planned implant osteotomy site.
The retrieved bone core specimens will be processed for histologic and histomorphometric evaluation. The analysis will assess the composition of the regenerated tissue, including newly formed bone, residual graft material, and non-mineralized connective tissue. These findings will help characterize the quality of bone healing after alveolar ridge preservation and provide information on the suitability of the regenerated site for implant-supported rehabilitation.
The study is designed to reflect routine clinical conditions and to evaluate biologic outcomes using tissue obtained during a standard step of implant therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients requiring tooth extraction, alveolar ridge preservation, and subsequent implant-supported rehabilitation.
- •Patients with an extraction site suitable for alveolar ridge preservation and delayed implant placement according to clinical and radiographic evaluation.
- •Patients able and willing to attend follow-up visits and undergo implant placement after the healing period.
- •Patients who provide written informed consent to participate in the study.
排除标准
- •Patients with uncontrolled systemic conditions that may interfere with wound healing or bone regeneration.
- •Patients with acute infection at the extraction site that, in the investigator's judgment, contraindicates alveolar ridge preservation.
- •Patients requiring major additional bone augmentation procedures at the extraction site beyond the planned alveolar ridge preservation procedure.
- •Pregnant or breastfeeding patients.
- •Patients with a history of head and neck radiotherapy, current chemotherapy, or other conditions that may compromise bone healing.
- •Patients unable to provide informed consent or comply with the study procedures.
研究组 & 干预措施
Alveolar Ridge Preservation Cohort
Participants in this cohort are adult patients requiring tooth extraction, alveolar ridge preservation, and subsequent implant-supported rehabilitation as part of their routine dental treatment. After tooth extraction, the socket will be treated with a bone graft material and covered with a membrane according to standard clinical procedures. Following the healing period, implant placement will be performed. During implant site preparation, a trephine bone core biopsy will be collected from the planned implant osteotomy site, from tissue that would otherwise be removed as part of the standard procedure. The collected samples will be used for histologic and histomorphometric evaluation of regenerated tissue composition.
干预措施: Alveolar Ridge preservation and early implant placement (Procedure)
结局指标
主要结局
Histomorphometric percentage of newly formed bone
时间窗: 2 months
Percentage of newly formed bone within the bone core biopsy obtained at implant placement. Histologic sections will be analyzed using histomorphometry, and newly formed bone will be expressed as a percentage of the total analyzed tissue area.
次要结局
- Implant stability measured by Implant Stability Test value(2 months)
研究者
Franco Cavalla
Full professor
University of Chile