Alveolar Ridge Preservation: Biologically-oriented Alveolar Ridge Preservation Vs Modified Periosteal Inhibition
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ridge width reduction
研究概览
简要总结
The modified periosteal inhibition technique has been proposed as an alternative to limit crestal resorption following tooth extraction in sockets with a residual vestibular thickness of <1 mm. This technique aims to prevent osteolytic activity on the external surface of a post-extraction socket by applying a 0.5 mm-thick soft cortical plate of porcine origin, secured with fibrin glue. By avoiding the placement of bone graft material inside the socket, the technique seeks to effectively counteract bone remodeling, achieving minimal reduction in the size of the alveolar crest.
The aim is to evaluate the effectiveness of the modified periosteal inhibition technique in preserving the dimensions of the alveolar ridge after tooth extraction, by comparing it with the Biologically-oriented Alveolar Ridge Preservation technique.
详细描述
The primary objective of the study is to clinically compare the effect on the preservation of the alveolar ridge using the modified periosteal inhibition technique and the Biologically-oriented Alveolar Ridge Preservation technique.
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: Observational study of a prospective non-profit cohort.
Study population: The study will be conducted in an outpatient hospital setting.
Number of patients to be enrolled to compare modified periosteal inhibition technique and BARP: 30 patients in the University of Trieste including dropouts.
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
- 否
入选标准
- •Age between 18 and 80 years;
- •Single-rooted tooth with indication for extraction with sockets having a residual thickness of <1 mm in the first 3 mm of the buccal residual crest presenting adjacent teeth;
- •American Society of Anesthesiologists 3;
- •Periodontal health or stability;
- •Signature of informed consent.
排除标准
- •Presence of periapical cystic lesions at the intervention sites;
- •Loss of bone tissue extending to the apical third on radiographic examination;
- •Extraction of adjacent teeth within a period ranging from 6 months prior to 6 months after the extraction;
- •Lack of one or more walls of the post-extraction socket;
- •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
ridge width reduction
时间窗: 26 weeks after tooth extraction and preservation tecnhique
optical scanning comparison measured in millimetres at the mid-buccal and mid-palatal aspect of the socket
ridge height reduction
时间窗: 26 weeks after tooth extraction and preservation tecnhique
optical scanning comparison measured in millimetres at the mid-buccal, mid-palatal, mesial and distal aspect of the socket
次要结局
- histologic and histomorphometric analysis of new bone formation(26 weeks after tooth extraction and preservation tecnhique)
- histologic and histomorphometric analysis of residual graft particles(26 weeks after tooth extraction and preservation tecnhique)
- histologic and histomorphometric analysis of marrow spaces(26 weeks after tooth extraction and preservation tecnhique)