To Evaluate the Clinical Outcomes of Horizontal (Lateral) Alveolar Ridge Augmentation Using Indigenously Prepared FDBA Block Graft and Amnion Chorion Membrane.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- • To evaluate the change in horizontal alveolar ridge width using FDBA block graft with Amnion-chorion membrane in deficient alveolar ridges.
研究概览
简要总结
Subjects will be screened from the outpatient Department of Periodontics, Maulana Azad Institute of Dental Sciences, New Delhi
Subjects who fulfill the inclusion criteria will be recruited for the study.
Phase 1 therapy, which includes scaling and root planing, will be done.
After 4 weeks of Phase 1 therapy, all clinical parameters were recorded ( Plaque index, gingival Index , alveolar ridge width at crest and 5mm apical to crest)
Horizontal ridge augmentation will be performed using an FDBA block graft fixed with titanium screws and Amnion chorion membrane
After 6 months, Phase II surgery will be performed, and all clinical parameters will be recorded again, followed by dental implant placement. Following that, statistical analysis will be carried out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with ridge defect with ridge width(RW) less than 4mm which was insufficient for standard implant placement.
- •Presence of maxillary or mandibular single or multiple (maximum 3 teeth loss) horizontal ridge defects.
- •Absence of any sign of pathology at the proposed surgical sites.
排除标准
- •Native Bone with any sign of pathology such as inflammation, or pus discharge.
- •Subjects with bone disease (Paget’s disease, rickets, osteoporosis, arthritis, multiple myeloma etc.) and Radiographic evidence of bone tumour (benign ormalignant) or any cyst.
- •Uncontrolled systemic diseases (uncontrolled diabetes, uncontrolled hypertension), taking immunosuppressive anticoagulant medications and pregnancy.
- •Subjects under longterm bisphosphonate therapy.
结局指标
主要结局
• To evaluate the change in horizontal alveolar ridge width using FDBA block graft with Amnion-chorion membrane in deficient alveolar ridges.
时间窗: baseline and after 6 months
次要结局
- To evaluate the clinical adverse effects of FDBA block graft and ACM, if any.(baseline and after 6 months)
研究者
Dr. Bhawana
Maulana Azad Institute of Dental Sciences