Evaluating the Effectiveness of Various Biomaterials for Alveolar Socket Preservation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of new bone formation in the extraction socket at 4 months
研究概览
简要总结
This clinical study aims to evaluate the effectiveness of different biomaterials in alveolar socket preservation following tooth extraction. Participants will be allocated into three groups: (1) dentin graft, (2) dentin graft combined with hyaluronic acid, and (3) natural healing without any grafting material (control group). At 4 months post-extraction, dental implants will be placed, and bone biopsies will be obtained during the procedure. These biopsy samples will be subjected to histological analysis to assess new bone formation and graft integration. The study will contribute to the understanding of biomaterial performance in socket preservation prior to implant placement.
详细描述
This randomized clinical trial is designed to evaluate the clinical and histological outcomes of different biomaterials used for alveolar socket preservation following tooth extraction. A total of 36 systemically healthy adult patients requiring tooth extraction in the non-molar region will be enrolled and randomly assigned to one of the following three groups (12 patients per group):
Group 1: Extraction socket filled with autogenous dentin graft.
Group 2: Extraction socket filled with autogenous dentin graft combined with hyaluronic acid.
Group 3 (Control): Extraction socket left to heal naturally without any graft material.
All patients will be re-evaluated at 4 months post-extraction, at which time dental implant placement will be performed. During the implant surgery, bone core biopsies will be taken from the grafted sites using a trephine bur for histological analysis. These specimens will be evaluated to assess new bone formation, residual graft material, inflammatory response, and overall bone quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Histological evaluator will be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Indicated for tooth extraction in the anterior or premolar region of the maxilla or mandible
- •Planned socket preservation and subsequent dental implant placement at the extraction site
- •Adequate bone volume permitting atraumatic extraction
- •Good oral hygiene and periodontal status compatible with socket preservation
- •Willing and able to attend scheduled follow-up visits and undergo biopsy collection prior to implant placement Able to provide written informed consent
排除标准
- •Systemic conditions known to impair bone or soft tissue healing (e.g., uncontrolled diabetes, immunosuppression, osteoporosis)
- •Current use of medications affecting bone metabolism (e.g., bisphosphonates, corticosteroids, anti-resorptives)
- •Active periodontal or periapical infection at the extraction site
- •History of head and neck radiotherapy
- •Smoking or tobacco use within the past 6 months
- •Pregnancy or breastfeeding
- •Known allergy or contraindication to grafting procedures or study-related materials
- •Inability or unwillingness to comply with follow-up visits or biopsy procedures
研究组 & 干预措施
Natural Healing
Extraction sockets are left to heal without the application of graft or biomaterial. Healing and gingival outcomes are evaluated at predefined time points.
Allograft
Participants receive an allograft material placed into the extraction socket. Healing and gingival parameters are assessed at predefined time points.
干预措施: Allograft (Other)
Dentin Graft
Participants receive autogenous dentin graft material placed into the extraction socket. Healing and gingival parameters are assessed at predefined time points.
干预措施: Autogenous Dentin Graft (Other)
Dentin + Hyaluronic Acid
Participants receive a combination of autogenous dentin graft and hyaluronic acid placed into the extraction socket. Healing and gingival parameters are assessed at predefined time points.
干预措施: Autogenous Dentin Graft (Other)
Dentin + Hyaluronic Acid
Participants receive a combination of autogenous dentin graft and hyaluronic acid placed into the extraction socket. Healing and gingival parameters are assessed at predefined time points.
干预措施: Hyaluronic Acid Gel (Other)
结局指标
主要结局
Percentage of new bone formation in the extraction socket at 4 months
时间窗: 4 months after tooth extraction
Histomorphometric analysis will be performed on biopsies harvested from the preserved sockets. The percentage of newly formed mineralized bone will be calculated as the ratio of new bone area to the total tissue area within the region of interest. Higher values indicate more favorable hard tissue regeneration in the socket preservation site.
次要结局
- Percentage of residual graft material in the extraction socket at 4 months(4 months after tooth extraction)
- Percentage of new connective tissue in the extraction socket at 4 months(4 months after tooth extraction)
- Percentage of newly formed vascularized tissue in the extraction socket at 4 months(4 months after tooth extraction)
- Change in buccolingual ridge width on CBCT from baseline to 4 months(Baseline and 4 months post-extraction)
- Change in buccal soft tissue thickness measured by intraoral scanner(Baseline and 4 months post-extraction)
- Change in width of keratinized mucosa from baseline to 4 months(Baseline and 4 months post-extraction)
- Change in soft tissue thickness over the preserved socket from baseline to 4 months(Baseline and 4 months post-extraction)
研究者
Okan Ozen
Research Assistant
Inonu University