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 β-TCP (Beta-Tricalcium Phosphate) improves alveolar ridge preservation (ARP) in patients who need tooth extraction. The main question it aims to answer is whether using β-TCP for alveolar ridge preservation has a positive effect on bone volume compared with natural healing.
The main questions it aims to answer are:
Does β-TCP improve ridge preservation compared with natural healing?
Researchers will compare β-TCP grafted sockets to natural healing sockets to see if β-TCP better preserves ridge volume.
Participants will:
Have a tooth indicated for extraction.
Be assigned to either β-TCP 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
Neocement Inject P® (Beta-Tricalcium Phosphate)
After tooth extraction the socket will be grafted with Neocement Inject P® (Beta-Tricalcium Phosphate).
干预措施: Neocement Inject P® (Beta-Tricalcium Phosphate) (Device)