Assessment of Safety and Performance of Neobone®: A Prospective Observational Study in the Field of Dentistry
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
The goal of this randomized clinical trial is to assess whether BCP (Biphasic Calcium Phosphate) improves alveolar ridge preservation (ARP) in patients who need tooth extraction. The main question it aims to answer is whether using BCP for alveolar ridge preservation has a positive effect on bone volume compared with natural healing.
The main questions it aims to answer are:
Does BCP improve ridge preservation compared with natural healing?
Researchers will compare BCP grafted sockets to natural healing sockets to see if BCP better preserves ridge volume.
Participants will:
Have a tooth indicated for extraction.
Be assigned to either BCP or natural healing.
Undergo CBCT (Cone Beam Computed Tomography) and intra-oral scanning after extraction and after six months of healing to measure horizontal and vertical resorption and bone density.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •Acceptance of informed consent
- •Type 1 or 2 extraction sockets (Elian et al. 2007)
排除标准
- •Presence of active infection or severe inflammation in the intervention zone
- •Relevant medical history that contraindicates implant surgery
- •Patients with poor oral hygiene (full-mouth plaque score and full-mouth bleeding score >15%) and lack of motivation
- •Uncontrolled diabetes (reported levels of glycated haemoglobin exceeding 7%)
- •Uncontrolled and /or untreated periodontal disease
- •Heavy smokers (more than 10 cigarettes per day)
- •Immunosuppression
研究组 & 干预措施
Neobone® (Biphasic Calcium Phosphate)
After tooth extraction the socket will be grafted with Neobone® (Biphasic Calcium Phosphate)
干预措施: Neobone® (Biphasic Calcium Phosphate) (Device)