The Adjunctive Effect of Platelet Rich Fibrin to Connective Tissue Graft in the Treatment of Buccal Recession Defects. Results of a Randomized Parallel Group Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Vertical Recession
研究概览
简要总结
The aim of the trial is to evaluate the effectiveness of coronally advanced flap (CAF)+connective tissue graft(CTG)+platelet-rich fibrin(PRF) combination in Miller I and II recession treatment by comparing with CAF+CTG. 40 patients were surgically treated either with CAF+CTG+PRF (test group) or CAF+CTG (control group). Clinical parameters of plaque index (PI), gingival index (GI), vertical recession (VR), probing depth (PD), attachment level (AL), keratinized tissue width (KTW), horizontal recession (HR), MGJ localization (L-MGJ), tissue thickness (TT) were recorded at baseline, 3 months (PS1) and 6 months (PS2) post-surgery. Root coverage (RC), complete RC (CRC), attachment gain (AG), and keratinized tissue change (KTC) were also calculated.
详细描述
Given the encouraging effects of platelet-rich fibrin (PRF) in healing and regeneration, it has been hypothesized that PRF might develop the outcomes obtained with coronally advanced flap (CAF)+connective tissue graft(CTG). Therefore, it was aimed to evaluate the effectiveness of CAF + CTG + PRF in Miller Class I and II recession defect treatment by comparing the outcomes with CAF + CTG in a preliminary, controlled, randomized clinical trial (RCT) with a 6-month follow-up. The study was conducted with 40 patients randomly grouped in half shares into indicated study groups. After phase I therapy, clinical variables including plaque index (PI), gingival index (GI), vertical recession (VR), probing depth (PD), attachment level (AL), keratinized tissue width (KTW), horizontal recession (HR), MGJ localization (L-MGJ), tissue thickness (TT) were recorded. The surgical sites were prepared by using sulcular and adjacent vertical incisions and CTGs were harvested from the palatal regions. Different from CAF+CTG group, PRF was prepared by obtaining 10 ml venous blood, centrifugation and extraction of the gel containing highly concentrated platelet cells in CAF+CTG+PRF patients. Then the gel was placed over the exposed root surface in the same group. The CAF was primarily closed and postoperative instructions were given. After suture removal at second postoperative week, the patients were followed-up by monthly recall visits. Same periodontal clinical variables were recorded 3 and 6 months after surgery.
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 (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy
- •Single Miller type I or II recession defect ≥ 3 mm localized to anterior/premolar area
- •No alveolar bone loss
- •Identifiable cemento-enamel junction
- •Probing depth ≤3mm
排除标准
- •Pregnancy
- •History of periodontal surgery in last two years
- •Excessive occlusal contacts
- •Loss of vitality
结局指标
主要结局
Vertical Recession
时间窗: Baseline, 6 weeks and 6 months
Measured from cementoenamel junction to margin of the gingiva by periodontal probe
次要结局
- Horizontal Recession(Baseline, 6 weeks and 6 months)
- Probing Depth(Baseline, 6 weeks and 6 months)
- Attachment Level(Baseline, 6 weeks and 6 months)
- Tissue Thickness(Baseline, 6 weeks and 6 months)
- Keratinized Tissue Width(Baseline, 6 weeks and 6 months)
研究者
H. Gencay Keceli
DDS, PhD
Kırıkkale University
