Use of Tilapia Skin for Palate Repair and Protection After Graft Removal
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Self-reported pain perception evaluated by a visual analog scale
研究概览
简要总结
Randomised Clinical Study to evaluate the efficacy of tilapia skin as an occlusive biological dressing on palatal wound healing after free gingival graft harvesting.
详细描述
Autogenous grafts are currently considered the gold standard in regenerative and reconstructive procedures. However, these procedures require a second surgical site to provide the tissue graft. In autogenous gingival grafts, the area commonly selected for graft harvesting is the palate, which is linked to great discomfort and morbidity for the patient. In order to overcome these limitations, xenogeneic and alloplastic materials have been tested as tissue substitutes, but their results are still considerably inferior when compared to autogenous grafts. Faced with this superiority, another approach to favor the use of autogenous grafting is to develop materials that provide greater postoperative comfort and patient safety. Since the main complaint arising from the technique is related to pain resulting from the remaining surgical wound on the palate, it is interesting to look for mechanisms to reduce this sensitivity and accelerate the healing process. For this, the use of tilapia skin as a postoperative dressing seems to be a good alternative. Thus, the purpose of this study is to evaluate the use of tilapia skin, with the intention of accelerating the palate healing process, and to serve as a protector barrier during the healing process. Patients treated according to two techniques for palate protection after autogenous gingival graft harvesting will be evaluated: C- use of surgical cement and T- use of tilapia skin. Will be selected 60 patients of both sexes,> 18 years old, requiring the removal of the palate graft for periodontal surgery. At the time of graft removal, palate thickness and graft dimensions will be measured. After 7, 14 and 30 days, the patient's discomfort and the difficulty in chewing and speaking will be recorded through a visual analog scale, the consumption of analgesic, and the dimensions of the surgical wound on the palate. For statistical analysis, two-way ANOVA will be performed and t-test paired on the obtained results.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients need periodontal or peri-implant surgical procedures requiring palate gingival graft
排除标准
- •Patients with an infectious condition that compromises the procedures
- •Users of drugs that can act on periodontal tissues or the healing process
- •Irradiated
结局指标
主要结局
Self-reported pain perception evaluated by a visual analog scale
时间窗: 14 days after the surgery
Patient's self-reported pain perception will be evaluated using a visual analog scale with a score ranging from 0 (no pain) to 10 (unbearable pain).
次要结局
- Self-reported trouble with eating evaluated by a visual analog scale(14 days after the surgery)
- Number of analgesic pills taken after surgery(14 days after the surgery)
- Self-reported discomfort evaluated by a visual analog scale(14 days after the surgery)
- Comparison of the palate healing process evaluated through linear measurements (millimiter)(30 days after the surgery)
- Self-reported trouble with speech evaluated by a visual analog scale(14 days after the surgery)
研究者
Gustavo Gonçalves do Prado Manfredi
Principal Investigator
University of Sao Paulo