Evaluation of Double Layer Graft Technique for Horizontal Ridge Augmentation With Staged Implant Placement (A Randomized Controlled Clinical Trial With Histological Assessment)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- clinical and radiographic outcome
研究概览
简要总结
clinical study with guided bone regeneration for deficient alveolar ridge to restore the defect in width and be able to place implant with two different technique
详细描述
This study will be conducted to compare the bone formation with double layer graft technique versus standard protocol in GBR for horizontal ridge augmentation with staged implant placement
Primary outcome: Evaluation of alveolar bone width gain clinically and radiographically.
Secondary outcome: Histological analysis of remodeled bone.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1- Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire. (American Society of Anesthesiologists I; ASA I) (Mombelli and Cionca, 2006) 2- Both genders. 3- Age from 20 - 40 years old. 4- Having missing maxillary or mandibular tooth with low or moderate horizontal defect (4-8) according to cologne classification (2013) 5- Presence of sufficient bone height minimum 12 mm that does not require bone grafting or any other ridge augmentation procedure.(Shah and Lum, 2008) 6- Presence of sufficient keratinized mucosa of at least 2 mm.(Bassetti, et al. 2015)
排除标准
- •1- Smokers (Twito and Sade, 2014) 2- Vulnerable groups (as pregnant females and decisional impaired individuals) will be excluded from the study.
- •3- Patients with poor oral hygiene or not willing to perform oral hygiene measures.
- •4- Prisoners and handicapped patients. 5- Patients with periodontal or periapical infections.(Tonetti, et al. 1996)
研究组 & 干预措施
double layer technique
include 9 patients will receive lateral alveolar ridge augmentation with double bone graft layer technique for GBR (first layer autograft followed by xenograft second layer
干预措施: Double layer technique (Procedure)
control
include 9 patients will receive lateral alveolar ridge augmentation with stander protocol for GBR technique (mixture of autograft and xenograft
干预措施: Double layer technique (Procedure)
结局指标
主要结局
clinical and radiographic outcome
时间窗: 6 months
clinical ridge width gain
次要结局
- histological analysis of remodeled bone.(6 months)
研究者
Leila Elraee Ibrahim
assistant lecture
Ain Shams University