The Use of L-PRF and A-PRF in Ridge Preservation: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes horizontal width at crest -1mm
研究概览
简要总结
A split-mouth design study will be performed regarding the use of platelet concentrates on ridge preservation: L-PRF vs A-PRF vs control. Patient needing multiple teeth extractions in the upper jaw (single-rooted teeth) will be recruited. The use of each platelet concentrate or control will be randomized by means of a computer program. The results will be analysed clinical and radiographically (CBCT). When the subject will choose for implant rehabilitation, a biopsy will be taken in the site of the preserved sockets. The region will be localized with a customized stent, fabricated with the position of the extracted teeth. VAS scales will be provided to evaluate the post-operative discomfort.
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
- •3 single-rooted teeth needed to be extracted in the upper jaw
- •patient in good general health as documented by self-assessment
- •patients must be committed to the study and must be willing to sing the informed consent.
排除标准
- •any systemic medical condition that could interfere with the surgical procedure or planned treatment.
- •current pregnancy or breast feeding
- •radiotherapy or chemotherapy in head and neck area
- •intravenous and oral bisphosphonate
- •patients smoking >20 cig/day
- •unwillingness to return for the follow-up examination
研究组 & 干预措施
L-PRF
One socket will be filled with L-PRF membranes and covered with at least 2 L-PRF membranes. A modified horizontal mattress will be place as suture to keep the L-PRF in place.
干预措施: L-PRF (Other)
A-PRF
One socket will be filled with A-PRF membranes and covered with at least 2 A-PRF membranes. A modified horizontal mattress will be place as suture to keep the A-PRF in place.
干预措施: A-PRF (Other)
Control
The socket will be filled with a natural blood clot. A modified horizontal mattress will be place as suture.
结局指标
主要结局
Changes horizontal width at crest -1mm
时间窗: 3 months
Primary outcome variables were defined as the changes in horizontal width at crest-1 mm levels.
次要结局
- Changes horizontal width at crest -3 mm and 5 mm; vertical resorption; socket fill(3 months)
研究者
Ana CASTRO SARDA
Doctoral researcher
Universitaire Ziekenhuizen KU Leuven