The Effect of Application of L-PRF in Periodontal Surgery on Clinical Parameters and Patient Related Outcome Measures: A Randomized, Controlled, Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Probing depth
研究概览
简要总结
The study will compare the clinical outcomes of the two procedures, open flap debridement (OFD) compared to open flap debridement with leukocyte and platelet-rich fibrin (L-PFR) as well as differences in patient postoperative pain perception.
详细描述
Randomization to one of two standard of care procedures:
- Test group: After gingival flap reflection and debridement of bone and root surfaces L-PRF will be applied to the alveolar bone, tooth roots, and gingival flap prior to suturing.
- Control group (Standard of care): Gingival flap reflection and debridement of bone and root surfaces, followed by suturing of the gingival flaps.
The study is a split-mouth design, randomized, prospective clinical trial. The protocol will randomize gingival quadrants in subjects to one of two standard of care procedures OFD or OFD + L-PRF. Patients needing periodontal surgery to correct periodontal disease will be enrolled. There will be two subject groups in this study. Each subject will be randomized to one of the treatments for the first quadrant and the contralateral quadrant will receive the other treatment. No risk is expected from being assigned to either group as both procedures are standard of care, with possible benefit of enhanced wound healing and bone regeneration in the test group.
Allocation of subjects into test group or control group will be based on numbers drawn from a stack of sealed envelopes.
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 (Participant)
盲法说明
Participants will be blinded to the intervention which they are randomized to.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between age 18 and 89
- •Patients needing open flap debridement procedures for periodontal disease in one or more teeth in the same arch bilaterally (split mouth)
- •Patients must be nonsmokers, former smokers, or current smokers who smoke <10 cigarettes per day, by self-report
- •Female patients to include non- pregnant women of child-bearing potential.
排除标准
- •Patients who disclose that they will not be able to cooperate with the follow-up schedule.
- •Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report)
- •Pregnant women or women intending to become pregnant during the study period
- •Smokers who smoke > 10 cigarettes per day
结局指标
主要结局
Probing depth
时间窗: 3 months and 6 months
Depth of gingival pocket
Postoperative Pain (PROM)
时间窗: 12 to 168 hours post surgery
Change in Patient reported outcome measures measured by a 10 point scale with 0 being no pain and 10 is the worst pain ever experienced.
次要结局
未报告次要终点