Effectiveness of "Pontic-shield" Technique in Alveolar Ridge Preservation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Bone resorption
研究概览
简要总结
Alveolar bone resorption after dental extraction frequently leads to situations in which long-term function and esthetic success of rehabilitations with dental implants is a challenge. "Pontic-shield" has been described as an alternative technique to maintain alveolar ridge after tooth extraction.
The aim of this study is to analyze the effectiveness of "Pontic-shield" technique in alveolar ridge preservation comparing to fresh socket and ridge preservation using deproteinized bovine bone and a porcine collagen membrane.
详细描述
A three-arm randomized clinical study will be conducted:
- Group 1 (study group): Ridge preservation with "Pontic-shield" technique.
- Group 2 (positive control): Ridge preservation with deproteinized bovine bone and porcine collagen membrane after tooth extraction.
- Group 3 (negative control): Tooth extraction only (fresh socket).
A cone-beam computed tomography will be performed prior to tooth extraction and 4 months postoperative. Radiographic changes between before and after intervention will be evaluated to asses the effectiveness of "Pontic-shield" technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Patient from 18 to 80 years old
- •Patients who sign the informed consent
- •Need to perform extraction from second premolar to second premolar in maxilla and mandible
排除标准
- •Tobacco consumption (more than 10 cigarettes per day)
- •Severe systemic disease ( ASA III or IV - American Society of Anaesthesiology)
- •Drug use that could interfere with alveolar bone healing
- •Active periodontal disease
- •Acute or chronic apical pathology of the tooth
结局指标
主要结局
Bone resorption
时间窗: From the day of the extraction to 4 months after
Radiographic changes between preoperative (prior to tooth extraction) and postoperative (4 months after intervention) will be analyzed. This variation will be assessed by measuring changes in width and height (in millimeters) of the socket by superimposition of CBCT before and after the intervention.
次要结局
- Satisfaction assessed by visual analogue scale (VAS)(From the day of the surgical procedure to the seventh-day)
研究者
Jesús Torres García Denche
Associate professor
Universidad Complutense de Madrid