Alveolar Ridge Preservation With Several Techniques: a Multicenter Observational Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- alveolar volume
研究概览
简要总结
Post-extractive alveolar ridge remodeling represents a physiological phenomenon that may hamper successive implant insertion. Several techniques have been proposed without any significant difference of efficacy among them. Moreover several research protocols of analysis have been proposed, including histomorphometric, radiological, clinical analysis.
The purpose of the present study is to test different alveolar ridge preservation techniques using histomorphometric and optical scanning analysis.
详细描述
Primary objective The primary objective of the study is to clinically compare the effect on the preservation of the alveolar ridge using different techniques (dental roots in association with platelet rich fibrin, BARP (Biologically-oriented Alveolar Ridge Preservation), Ice Cream Cone Technique and unassisted socket healing).
Secondary objective The secondary objective is the collection of histological and histomorphometric data that allow to evaluate the quality and quantity of newly formed bone.
Study design Multicenter observational study of a prospective non-profit case-control.
List of centers involved in addition to our facility:
- University of Porto, Faculty of Dentistry, Specialization in Periodontology and Implantology.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 80 years;
- •Single-rooted tooth with indication for extraction and presenting adjacent teeth;
- •Presence of type II defect;
- •Sufficient bone height of the extraction site for the insertion of a standard implant (≥8.5 mm);
- •Healthy oral mucosa with at least 3 mm of keratinized tissue;
- •American Society of Anesthesiologists 3;
- •Periodontal health or stability;
- •Signature of informed consent.
排除标准
- •Presence of general contraindications for oral surgery;
- •Presence of inflammatory and autoimmune diseases;
- •Uncontrolled diabetes (HbA1c 7%);
- •History of tumors requiring chemotherapy or radiotherapy in the last 5 years;
- •Previous therapy with bisphosphonates or high-dose corticosteroid therapy;
- •Smoking (10 cigarettes/day);
- •Allergy to bovine collagen;
- •Pregnancy or breastfeeding;
- •Lack of compliance.
结局指标
主要结局
alveolar volume
时间窗: 6 months post-extractive
optical scanning comparison
次要结局
- histomorphometric analysis(6 months post-extraction)
研究者
Mr. Claudio Stacchi, DDS, MSc
Head of Scientific committe of International Piezosurgery Academy
International Piezosurgery Academy