EVALUATION OF THE EFFECT OF POLYVINYLPYROLIDONE AND SODIUM HYALURONATE GEL ON PALATINAL WOUND HEALING: A RANDOMIZED CONTROLLED CLINICAL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Epithelialization
研究概览
简要总结
The aim of this clinical study was to evaluate the effect of polyvinylpyrrolidone sodium hyaluronate gel on palatal wound healing, pain, and bleeding after free gingival graft surgery. This study included 32 systemically healthy patients who required free gingival graft surgery. After the operation, the test group received polyvinylpyrrolidone sodium hyaluronate gel in addition to chlorhexidine gluconate mouthwash, whereas the control group received only chlorhexidine gluconate mouthwash. VAS scale was used to evaluate palatal pain, burning, and chewing discomfort, WHI was used to evaluate wound healing, and H2O2 foaming test was used to evaluate epithelialization. VAS and bleeding values were recorded on postoperative day 1; VAS, WHI, H2O2, and bleeding values on postoperative days 3, 7, and 14; and WHI, H2O2, and bleeding values on postoperative day 28.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to adapt to the study, not having a physical or psychological condition that would prevent surgical procedure under local anesthesia, and being able to follow the planned operation and control sessions
- •Patients who consciously accept and sign the detailed informed consent form regarding the study that will be explained to them verbally
- •Insufficiently attached gingiva on the mandibular or maxillary vestibular teeth and implant surfaces
排除标准
- •Presence of infection and inflammation in the recipient and donor area
- •Presence of systemic disease
- •Women who are pregnant, suspected of being pregnant or breastfeeding
- •Orofacial neurological symptoms
结局指标
主要结局
Epithelialization
时间窗: 28 days
Epithelialization of the palatal region was performed by applying 3% hydrogen peroxide to the wound area with the help of an injector, and the areas showing foaming (H2O2 bubbling) in the total surface area of the wound area were calculated as a percentage and recorded, providing information about epithelialization.
次要结局
- wound healing(28 days)
研究者
nuray Ercan
ASSISTANT PROFESSOR
Abant Izzet Baysal University