The Effect of Two Different Approaches on Palatal Donor Site Management After De-epithelialized Graft Harvesting: Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Donor site pain perception
研究概览
简要总结
An epithelialized gingival graft will be harvested from the palate for the treatment of various mucogingival deformities. The donor site will be treated with either a combination of a collagen sponge, cyanoacrylate and suspending sutures or a collagen sponge, cyanoacrylate, suspending sutures and coconut oil.
详细描述
After epithelialized gingival graft harvesting, intraoperatively, measurements will be taken for palatal tissue thickness, graft dimensions, working time, and primary bleeding time. Data regarding pain perception will be gauged using a visual analog scale, and the number of analgesics, secondary bleeding, epithelization level, and color match will be assessed prospectively. These outcomes will be evaluated on the first 7 days and subsequently on the 14th, 21st, and 28th days. Patient-reported outcomes will be recorded using the Oral Health Impact Profile-14 questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (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
- •age ≥18; mucogingival surgical treatment indication that needs connective tissue graft in the anterior mandible; stable periodontium after phase I therapy; full-mouth plaque and bleeding scores <15%
排除标准
- •previous palatal harvesting history; unstable endodontic conditions; tooth mobility at the surgical site; systemic disease; pregnancy; use of medications with potential adverse effects on periodontal tissues
结局指标
主要结局
Donor site pain perception
时间窗: everyday in first week
Patients score their daily donor site pain perception using visual analog score level by giving numbers from 0 to 10 according to the visual analog scale (0: no pain, 1: minimal pain, 10: severe pain)
Secondary bleeding time
时间窗: during first week
Patients will record presence or absence of secondary bleeding (presence=1 or absence=0).
次要结局
- Graft height(during surgery)
- Graft width(during surgery)
- Graft thickness(during surgery)
- Working time(during surgery)
- Quantity of analgesics(first week)
- Sensation loss(first week, second week , third week, fourth week.)
- Color match(first week, second week, third week, fourth week.)
- Epithelization level(first week, second week, third week, fourth week.)
- The Oral Health Impact Profile-14 is a questionnaire that measures how oral disorders impact a patient's quality of life.(first week)
研究者
Melis Yilmaz
DDs, PhD
Medipol University