Clinical and Biochemical Evaluation of Platelets Rich Fibrin (PRF) and Nanohydroxyapatite in the Treatment of Intrabony Defects
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in Gingival crevicular fluid (GCF)
研究概览
简要总结
Background: the ultimate goal of periodontal therapy is the regeneration of periodontal tissues. Researches had demonstrated the benefits of platelet concentrates bine grafts in osseous regeneration in the areas of periodontal surgery.
Aim of the study: to evaluate the effect of PRF with/without nanohydroxyapatite in periodontal intrabony defects.
详细描述
Background: the ultimate goal of periodontal therapy is the regeneration of periodontal tissues. The regenerative and wound healing potential of platelets has attracted much attention over the last few years. Researches had demonstrated the benefits of platelet concentrates in osseous regeneration in the areas of periodontal surgery and implantology. In addition, nanohydroxyapatite was shown to be unsheathed by newly formed bone and partly replaced by it, but resorbed very slowly, as shown in animal experiments after 9 months or in clinical studies after a 6-month observation period. The clinical and biochemical studies evaluating the regenerative effect of PRF alone or in combination with nanohydroxyapatite in periodontal intrabony defects are still deficient.
Aim of the study: to evaluate clinical and biochemical effect of PRF with/without nanohydroxyapatite in treatment of human intrabony defects.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients are free from systemic illness.
- •All patients should be diagnosed as having chronic periodontitis.
- •Patients should be cooperative, motivated and willing to follow our treatment protocol and follow up visits.
- •Patients selected had not received antibiotics or anti-inflammatory therapy in the 6 months prior to examination.
排除标准
- •Presence of areas of periodontal pocket of (probing depth ≥5 and clinical attachment level (CAL) ≥ 3).
- •Patients who have received any type of periodontal treatment in the past 6 months prior to examination.
研究组 & 干预措施
OFD alone
Control group: including 15 defects that will receive open flap debridement (OFD).
干预措施: OFD alone (Procedure)
PRF + OFD
Test group (1): including 15 defects that will receive platelet rich fibrin (PRF) with open flap debridement (OFD).
干预措施: OFD alone (Procedure)
PRF + OFD
Test group (1): including 15 defects that will receive platelet rich fibrin (PRF) with open flap debridement (OFD).
干预措施: Platelet rich Fibrin (Drug)
Bone + OFD
Test group (2): including 15 defects that will receive nanohydroxyapatite bone graft with open flap debridement OFD).
干预措施: OFD alone (Procedure)
Bone + OFD
Test group (2): including 15 defects that will receive nanohydroxyapatite bone graft with open flap debridement OFD).
干预措施: Nanohydroxyapatite (Drug)
PRF + Bone + OFD
Test group (3): including 15 defects that will receive nanohydroxyapatite bone graft with platelet rich fibrin (PRF) after open flap debridement (OFD).
干预措施: OFD alone (Procedure)
PRF + Bone + OFD
Test group (3): including 15 defects that will receive nanohydroxyapatite bone graft with platelet rich fibrin (PRF) after open flap debridement (OFD).
干预措施: Platelet rich Fibrin (Drug)
PRF + Bone + OFD
Test group (3): including 15 defects that will receive nanohydroxyapatite bone graft with platelet rich fibrin (PRF) after open flap debridement (OFD).
干预措施: Nanohydroxyapatite (Drug)
结局指标
主要结局
Changes in Gingival crevicular fluid (GCF)
时间窗: up to 3 weeks.
GCF will be collected after removing saliva and supra-gingival plaque using methylcellulose filter paper strip that will be inserted in the periodontal pocket and will be let in for 30 seconds.
次要结局
- Changes in Gingival index(up to 3 months)
- Changes in level of attachment loss(up to 3 months)
- Changes in probing pocket depth(up to 3 months)
研究者
Maha A. Bahammam
Associate Professor and Consultant of Periodontology
King Abdulaziz University