Bovine-derived Xenograft (Bio-Oss Collagen) With or Without Leukocyte-platelet Rich Fibrin (L-PRF) for Alveolar Ridge Preservation After Tooth Extraction: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 34
- 主要终点
- Implant survival / success rate will be assessed clinically after one year of implant restoration and annually up to three years.
研究概览
简要总结
The study is prospective randomized clinical trial that aims to evaluate the adjunctive use of L-PRF in promoting the desired vascularization and bone fill in small and large defects following tooth extraction and report on the long-term implant and patient outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 or over.
- •Require extraction of anterior or posterior single tooth due to caries, endodontic and prosthetic complications.
- •The tooth that requires extraction is bordered by two teeth.
- •Controlled oral hygiene (full-mouth plaque and bleeding scores ≤ 25% at baseline).
- •Good compliance and commitment to attend follow-up review appointments.
- •Willing to provide informed consent.
排除标准
- •Localised / generalised periodontitis.
- •Presence of acute periapical lesion.
- •Bone metabolic disease and/or taking medications that affect bone metabolism.
- •Long term use of non-steroidal anti-inflammatory medications.
- •History of malignancy, radiotherapy or chemotherapy.
- •Pregnant or lactating women.
- •Severe bruxism or parafunctional habits.
- •Large occlusal discrepancies.
研究组 & 干预措施
Control group (C)
Xenograft + resorbable collagen membrane
干预措施: Alveolar ridge preservation using sticky bone (Procedure)
Test group (T)
Xenograft combined with L-PRF + resorbable collagen membrane
干预措施: Alveolar ridge preservation using sticky bone (Procedure)
结局指标
主要结局
Implant survival / success rate will be assessed clinically after one year of implant restoration and annually up to three years.
时间窗: 2 years
Patient postoperative experience will be assessed using visual analogue scale during the first week following tooth extraction and ridge preservation.
时间窗: 2 years
Reporting a score will be done using the pain visual analogue scale. Minimum value is 0 which is no pain and maximum value is 10 which is the worst pain ever experienced.
次要结局
- Need for additional bone augmentation will only be assessed at the time of implant placement by recording the use of bone graft (if required) in the clinical notes.(2 years)
- Changes in peri-implant marginal bone level will be assessed at implant placement (baseline) and after one year of implant restoration and annually up to two years using standardized peri-apical radiograph.(2 years)
- Soft tissue levels (midbuccal marginal tissue level changes, interproximal papilla level changes and changes in width of keratinised tissue) will be assessed at implant placement (baseline), at 1 year and at 2 years(2 years)
- Changes in width and height of alveolar ridge will be assessed at the time of tooth extraction and ridge preservation, six months (prior to implant placement) and annually up to two years using cone beam computed tomography (CBCT).(2 years)
- Biological complications (i.e. peri-implant diseases) will be assessed clinically using periodontal probe after one year of implant restoration and annually up to two years.(2 years)
研究者
Abeer Hakam
Assistant professor
Mohammed Bin Rashid University of Medicine and Health Sciences