TiO2-scaffolds for Alveolar Ridge Preservation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Adverse reactions
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety of placing TiO2 scaffolds in alveolar ridge and to evaluate if the scaffold material contributes to maintain the anatomy and the volume of the alveolar process after tooth extraction.
详细描述
The primary objective of the clinical trial is to evaluate the safety of placing TiO2 scaffolds in alveolar ridge.
The secondary objectives are; (1) to assess anatomical changes as measured by intraoral digital scanning at the time of extraction, after 6 months. (2) to evaluate soft tissue inflammation at 1, 2, 4, 12 and 24 weeks post-surgery, (3) to assess the preservation of the alveolar ridge following placement of TiO2 scaffold in the alveolae after tooth extraction, (4) to assess bone mineralization and quantitative healing in bone biopsies obtained at implant installation in the preserved site 6 months following treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must be ≥ 20 years, and present with a molar or premolar planned for extraction
排除标准
- •Individuals with medical conditions that may affect soft tissue or bone metabolism
- •Previous local radiotherapy
- •Current use of chemotherapy
- •Systemic long-term corticosteroid treatment.
- •Smokers (> 10 cigarettes/day).
- •Patients with active of untreated periodontal disease.
- •Present or past use of bisphosphonate treatment
- •Pregnant or nursing subjects
- •> class 2 according to the ASA (American Society of Anesthesiologists) physical status classification
- •Acute infection or no apical periodontitis visible on radiograph of tooth planned for extraction.
结局指标
主要结局
Adverse reactions
时间窗: Through study completion, an average of 1 year
Evaluate and register any adverse reactions following placement of the scaffold
次要结局
- Inflammation(Through study completion, an average of 1 year)
- Anatomy(6 months after surgery)
- Mineralization(Evaluation of the histology, specimens tasken 6 months after surgery.)
研究者
Jan Eirik Ellingsen
Professor
University of Oslo