Randomized Controlled Clinical Trial Pilot Study: Patient Outcomes and Gingival Blood Flow Using Laser Doppler Flowmetry Following the Use of Episil on Free Gingival Graft Donor Sites
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
研究概览
简要总结
The hypothesis for the present study is that patient-based outcomes and gingival blood flow will be more favorable for the free gingival graft (FGG) donor sites being covered by the test wound dressing material episil compared to the control dressing.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient of record at UTHealth School of Dentistry Houston Texas
- •signed treatment plan for a FGG
- •the ability to provide research informed consent
排除标准
- •any allergies to any of the ingredients in episil including allergies to peanuts, soy or peppermint oil
- •pregnant or breast feeding women
- •inability or unwillingness to provide informed consent
结局指标
主要结局
Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
时间窗: 21 days postoperatively
Postoperative pain will be determined by the subjects recording the number of analgesic pills taken each day.
Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
时间窗: 21 days postoperatively
Postoperative pain will be determined by the subjects recording their postoperative pain threshold using a Visual Analog Scale with scores from 1 to 10, with 1 indicating minimal pain and 10 indicating severe pain. If no pain is present, a score of 0 will be given. The levels of postoperative pain will be classified as none to minimum if the score is "0 to 3," moderate for "4 to 6," and severe for "7 to 10." None to minimal pain will mean little or no discomfort; moderate is any pain that bothers the subject and mildly affects normal function; and severe will be considered any pain that will not be tolerated and may even disrupt the subject's daily functions.
次要结局
- Gingival Blood Flow as Measured Laser Doppler Flometry (LDF)(baseline (on the day of surgery before surgery))
- Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test(21 days postoperatively)
- Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)(21 days postoperatively)
研究者
Jennifer James
Clinical Assistant Professor
The University of Texas Health Science Center, Houston