A comparative clinical study to evaluate the healing of palatal donor site after harvesting free gingival graft with and without using platelet rich fibrin as a biological dressing
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Comparing the enhanced wound healing of the palatal donor site with and without using PRF as a biological dressing.
研究概览
简要总结
The root coverage procedures are performed for the correction of gingival recession, which is necessary for aesthetic demands, root hypersensitivity, root carious lesions, and cervical abrasions. One of the treatment modalities performed for the gingival recession is free gingival graft(FGG). The keratinized gingiva of the hard palate is one of the common sites for obtaining a free soft tissue graft for periodontal plastic surgical procedure. They yield excellent clinical results and are considered superior. The disadvantages of free gingival grafts are requirement of second surgical site, tissue necrosis, hemorrhage, discomfort and pain. the donor site healing occurs by secondary intention and it takes about 2-4 weeks for the healing to be complete. There is very minimal literature evidence to overcome the disadvantages of the free gingival graft procedure. Choukroun’s platelet rich fibrin is a second generation platelet concentrate that is used in wound healing of skin wounds and recent evidences suggest application of PRF for various modalities in the periodontal therapy. The PRF has stimulatory effect on wound healing due to the presence of various growth factors and also acts as an excellent scaffold for angiogenesis and epithelialisation.
This study is time bound (18 Months) randomized controlled clinical trial, patients fulfilling the inclusion and exclusion criteria during the study period will be recruited for the study. This study is aimed to evaluate the palatal wound healing after free gingival graft procedure by comparing the healing parameters, cytological study and VAS score of the recruited subjects whose palatal wounds are to dressed with PRF as a biological dressing with those whose wounds are not to be treated with a biological dressing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 64.00 Year(s)(—)
- 性别
- All
入选标准
- •Subjects indicated for free gingival graft procedure.
- •Subjects willing to give informed consent to participate in the study.
排除标准
- •Subjects suffering from any debilitating condition.
- •Immuno-compromised subjects.
- •Pregnant women -Lactating mothers -Subjects with habits like alcoholism, smoking, chewing tobacco.
- •Subjects under Anti-coagulant medication.
结局指标
主要结局
Comparing the enhanced wound healing of the palatal donor site with and without using PRF as a biological dressing.
时间窗: the patient is assessed at 10th, 20th, and 30th days post operatively.
次要结局
- Patient comfort/discomfort is assessed using VAS score(the patient is assessed at 10th, 20th, and 30th days post operatively.)
