Evaluation of the Efficacy of Xenograft Containing Hyaluronic Acid in Socket Preservation Procedure Radiologically and Histologically: A Prospective Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- bone formation
研究概览
简要总结
Bone loss due to resorption is commonly observed in the alveolar socket following tooth extraction. This situation makes it difficult to preserve sufficient bone volume that would allow for ideal implant placement in cases requiring dental implants. Alveolar ridge preservation is a procedure aimed at minimizing bone resorption and preserving the volume and morphology of the alveolar ridge after tooth extraction.
The aim of this study is to evaluate the clinical effectiveness of socket preservation using a xenograft enriched with hyaluronic acid in patients with defective extraction sockets.
This study is designed as a randomized, controlled clinical trial including three parallel groups:
Study group - Patients whose alveolar bone was evaluated using cone-beam computed tomography (CBCT) will undergo tooth extraction, followed by the application of a bovine-derived graft/xenograft enriched with hyaluronic acid into the socket. Patients will be evaluated clinically, radiologically, and histologically at the 4th month. Dental implants will be placed in the edentulous areas where the graft was applied. Bone samples will be taken during the preparation of the implant sockets, and the bone tissue will be examined histologically. A third CBCT scan will be taken 6 months after implant placement to assess new bone formation and implant success radiographically.
Comparison group - Patients whose alveolar bone was evaluated using CBCT will undergo tooth extraction, followed by the application of a standard bovine-derived graft/xenograft into the socket. Patients will be evaluated clinically, radiologically, and histologically at the 4th month. Dental implants will be placed in the edentulous areas where the graft was applied. Bone samples will be taken during the preparation of the implant sockets, and the bone tissue will be examined histologically. A third CBCT scan will be taken 6 months after implant placement to assess new bone formation and implant success radiographically.
Control group - Patients whose alveolar bone was evaluated using CBCT will undergo tooth extraction, and the socket will be left to heal naturally without the application of any graft material. Patients will be evaluated clinically, radiologically, and histologically at the 4th month. Dental implants will be placed in the edentulous areas. Bone samples will be taken during the preparation of the implant sockets, and the bone tissue will be examined histologically. A third CBCT scan will be taken 6 months after implant placement to assess new bone formation and implant success radiographically.
详细描述
Following tooth extraction, volume loss due to bone resorption is observed in the alveolar socket. This condition complicates the preservation of sufficient bone volume that would allow for ideal implant placement in cases requiring dental implants. Alveolar ridge preservation is a procedure aimed at minimizing bone resorption and maintaining the volume and morphology of the alveolar ridge after tooth extraction. In this procedure, the goal is to provide structural support and a scaffold for new bone formation by using materials such as autogenous grafts, allografts, xenografts, barrier membranes, platelet-rich fibrin, bone morphogenetic proteins, and other growth factors. This approach supports bone regeneration by promoting osteogenesis and osteoconduction. Although current methods maintain their effectiveness, variability in outcomes is still observed. This highlights the need for more extensive research into different graft materials and innovative approaches.
Hyaluronic acid has emerged as a promising biomaterial for alveolar ridge preservation due to its multifaceted biological effects on tissue regeneration and wound healing. Its viscoelastic properties help maintain hydration and structural integrity at the graft site, reducing graft shrinkage and supporting vertical stability. Additionally, by interacting with cell surface receptors, it stimulates osteoblast activity and inhibits osteoclastogenesis, thereby contributing to increased bone density and improved biointegration of the graft material. Clinical studies have also demonstrated that hyaluronic acid enhances angiogenesis, strengthening the osteoconductive properties of graft materials and optimizing clinical outcomes in alveolar ridge preservation.
The aim of this study is to evaluate the clinical efficacy of socket preservation using a xenograft enriched with hyaluronic acid in patients with defective extraction sockets. Over a 10-month period, the study group receiving a hyaluronic acid-enriched xenograft will be compared with a control group receiving a standard xenograft and another control group left to natural healing after tooth extraction. Evaluated outcomes include horizontal and vertical bone gain, graft stability, residual graft, bone marrow presence, and bone mineral density.
This study is designed as a randomized, controlled clinical trial including three parallel groups:
Study group - Patients whose alveolar bone is pre-evaluated using cone-beam computed tomography (CBCT) will receive a bovine-derived graft/xenograft enriched with hyaluronic acid in the extraction socket after tooth removal. Patients will be evaluated clinically, radiologically, and histologically at 4 months. Dental implants will be placed in the edentulous areas where the graft was applied. Bone samples will be collected during the preparation of the implant sockets and analyzed histologically. A third CBCT scan will be performed 6 months after implant placement to radiographically assess new bone formation and implant success.
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
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
- 是
入选标准
- •Socket type: Sockets with less than 50% bone resorption in the buccal and palatal/lingual walls according to the Kim JJ classification (Type I-IVa)
- •Age range: 18-65 years
- •Absence of active periodontal disease
- •No systemic diseases
- •Patients who will attend regular follow-up visits
排除标准
- •Uncontrolled systemic disease
- •Presence of infection in the area
- •Use of medications affecting bone metabolism
- •Pregnancy or lactation
结局指标
主要结局
bone formation
时间窗: until the end of the histological examination 4 months after the socket preservation procedure
At the 4-month follow-up, dental implants will be placed in the edentulous areas where grafts were applied. During the preparation of the implant sockets, bone samples will be collected and examined histologically. Tissue samples obtained for histological examination will be fixed in a 10% formaldehyde solution for 72 hours. Following fixation, the tissues will undergo a decalcification process. After decalcification, a routine histological tissue processing protocol will be applied. The obtained histological images will be evaluated according to the classification by Jerry Bouquot. Tissues obtained from the study will also be analyzed using immunohistochemical staining under a light microscope (Olympus BX51, Tokyo, Japan). The sections will be examined under a light microscope (Olympus BX51, Tokyo, Japan). For all femoral sections obtained from subjects in the experimental groups, the intensity of AP and TRAP immunoreactivity will be calculated at 40× magnification using the ImageJ.
次要结局
- Radiographic bone evaluation(up to the radiographic evaluations at 4 and 10 months after the socket preservation procedure)