Evaluation of the Usage of Platelet-Rich Fibrin Dressing in the Management of Free Gingival Graft and Donor Site Palatal Wound
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The pain score using the visual analogue scale (VAS)
研究概览
简要总结
Evaluation of two dressing materials; a Platelet-Rich Fibrin (PRF) dressing and a non-eugenol-based (Coe-Pak™) dressing in the management of free gingival graft and donor site palatal wound.
详细描述
Evaluation of the usage of platelet-rich fibrin dressing in the management of free gingival graft and donor site palatal wound by evaluation of pain score, healing tissue in both donor and receiving sites, coverage of gingival recession, and the gain of attached gingiva.
A total of 20 subjects will be invited to participate in this study from the patients seeking treatment at the Department of Periodontology, Faculty of Dentistry, Damascus University.
The study has been approved by the investigator's local Review Board. Subjects will be recruited according to specific inclusion criteria. After completion of medical and dental history questionnaires, patients will sign a consent form after being advised about the nature of the study.
Patients will be allocated into two groups (10 patients each). A Platelet-Rich Fibrin (PRF) dressing will be used in both donor and receiving sites in the test group, while a non-eugenol-based (Coe-Pak™) dressing will be used in both donor and receiving sites in the control group .
Donor site working time, bleeding (BLE), colour match (CM), pain and re-epithelization (EP) will be evaluated.
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
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of Syrian descent.
- •Systemically healthy.
- •Attached gingival width ≤ 2 mm.
- •Presence of type II (Miller Classification) of gingival recession.
排除标准
- •Pregnancy or lactating.
- •Presence of any systematic diseases can affect the periodontal surgery.
- •Subjects with significant moderate to severe periodontal disease.
- •Patients under orthodontic treatment
- •Presence of restorative materials (e.g. crown)
- •Subjects have failed to maintain good plaque control.
- •Subjects having previous surgical treatment for covering the recession in the chosen area.
研究组 & 干预措施
A Platelet-Rich Fibrin dressing
A Platelet-Rich Fibrin dressing (PRF) will be used in both donor and receiving sites after a free gingival graft.
干预措施: A free gingival graft (Procedure)
A Platelet-Rich Fibrin dressing
A Platelet-Rich Fibrin dressing (PRF) will be used in both donor and receiving sites after a free gingival graft.
干预措施: A Platelet-Rich Fibrin dressing (Device)
A non-eugenol-based dressing
A non-eugenol-based dressing (Coe-Pak™) will be used in both donor and receiving sites after a free gingival graft.
干预措施: A free gingival graft (Procedure)
A non-eugenol-based dressing
A non-eugenol-based dressing (Coe-Pak™) will be used in both donor and receiving sites after a free gingival graft.
干预措施: A non-eugenol-based dressing (Device)
结局指标
主要结局
The pain score using the visual analogue scale (VAS)
时间窗: The Pain score will be evaluated twice. At T1 (after 2 days of surgery) and T2 (after 7 days of surgery).
This variable is going to be measured by an visual analogue scale (VAS). The VAS pain scores ranges between 0 to10. (0: no pain, 1: minimal pain, 10: severe pain).
次要结局
- Attached gingival width(The measurement will be performed at T0 (baseline measurement) and at T1 (after 3 months measurement).)
- Plaque index(The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).)
- Gingival Index(The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).)
- Match color of the palatal wound(The measurement will be performed at T1 (after 1 week measurement) and T2 (after 1 month measurement).)
- Bleeding on probing Index(The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).)
- Changes in gingival recession(The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).)
- Healing index for free gingival graft(The healing index will be evaluated twice. At T1 (after one week of surgery) and T2 (after one month of surgery)..)
- The complete re-epithelialization of the palatal wound(The measurements will be performed at T1 (after 1 week measurement), T2 (after 2 weeks measurement), T3 (after 3 weeks measurement), and T4 (after 4 weeks measurement).)
- Pocket Probing Depth(The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).)