Efficacy of Collagen Sponge on Palatal Wound Healing: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- epithelialization of the palatal wound evaluated by hydrogen peroxide test
研究概览
简要总结
The aim of this study is to compare the efficacy of collagen sponge and gelatin sponge on the palatal wound healing and postoperative pain following gingival graft harvesting.
详细描述
The aim of this study is to compare the efficacy of collagen sponge and gelatin sponge on the palatal wound healing and postoperative pain following gingival graft harvesting. The included patients will be randomized into two groups. The patients in control group will be treated with gelatin sponge and those in the test group will be treated with collagen sponge. The postoperative pain will be assessed by VAS scale at day 1, 3 and 7 after surgery. Epithelialization of the palatal wound will be evaluated by hydrogen peroxide test and digital photography at 1 week postoperatively. Additionally, postoperative pain, consumption of analgesics, willingness to repeat the treatment and the existence of delayed bleeding will be recorded at 1 week. At 2 weeks, 3 weeks and 1 month after surgery, epithelialization of the palatal wound and aesthetic scores 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Clinical indications utilizing free gingival grafts or de-epithelialized gingival grafts to treat either insufficient keratinized tissue or gingival recession defects
- •Full-mouth plaque score and full-mouth bleeding score lower than 20%
排除标准
- •Pregnancy or lactation
- •Untreated periodontal disease
- •Severe systemic conditions that contraindicate surgery (diabetes, heart disease, cancer etc.)
- •Presence of coagulation disorders (history of Haemophilia, von Wille-brand disease, or anticoagulant therapy)
- •Taking medications affecting periodontal health or healing
- •Previous surgery for a palate graft harvested from the experimental sites
结局指标
主要结局
epithelialization of the palatal wound evaluated by hydrogen peroxide test
时间窗: at 1 month
The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).
epithelialization of the palatal wound evaluated by digital photography
时间窗: at 1 month
The epithelialization of the palatal wound will be recorded as "yes" or "no" according to inspectional evaluation of surface characteristics and reflection as well as clarity and distinctness of wound outline.
次要结局
- consumption of analgesics(at 1 week)
- the existence of delayed bleeding(at 1 week)
- postoperative pain(at day 7)
- willingness to repeat the treatment(at 1 week)
- aesthetic score(at 1 month)
研究者
Peihui Ding
Deputy Chief Physician
The Dental Hospital of Zhejiang University School of Medicine