Effect of Topically-Applied Hyaluronic-Acid on Palatal Epithelial Wound Closure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Pain
研究概览
简要总结
Aim of the study is to assess the therapeutic effects of topical hyaluronic-acid use on secondary wound healing of the free gingival graft donor site. The hypothesis of this study is that topical hyaluronic-acid gel has positive effects on secondary wound healing of free gingival graft donor site by reducing pain, burning sensation, and accelerating the healing.
详细描述
The objective of the randomized, single blind, controlled and parallel clinical trial was to assess therapeutic effects of topical hyaluronic-acid on secondary wound healing of free gingival graft donor site.
Primary outcome variables that pain and burning sensation changes were assessed at 3, 7, 14, 21 days after surgery by the examiner. Pain and burning sensation were assessed by patients using the VAS, score 0 indicate no pain or burning sensation, score 10 indicate severe pain or burning sensation. Secondary outcome variables included color match, consistency and epithelization of the wound area. These parameters were assessed by the same examiner at 3, 7, 14, 21 and 42 days after surgery. Color of the palatal mucosa was assessed by comparing it to that of the adjacent and opposite site using the VAS. Score 0 indicate no color match and score 10 indicate very good color match. Consistency of the palatal mucosa was assessed with a blunt instrumentation and scored as soft or firm. Epithelialization was scored clinically as none, partial or complete.
Sample size has been estimated in 12 subjects per treatment groups. Random allocation of the treatment sites to test and control groups will be performed using a computerized selection of random numbers for allocation of the study groups.
Clinical images obtained at baseline, 3, 7, 14, 21 and 42 days after surgery from each treatment site.
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 (Participant)
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
- •Good general health
- •No periodontal surgical treatment in the previous 6 months on the involved sites
排除标准
- •Patients with a pregnancy or lactation period
- •Self-reported history of antibiotic medication within three months
- •Absence of tooth in the area of donor site
研究组 & 干预措施
Periodontal dressing material
Palatal wound area was covered with periodontal dressing material at baseline and 3rd day
干预措施: Periodontal dressing material (Drug)
0.2% Hyaluronic acid gel
0.2% topical hyaluronic-acid gel was applied to palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day
干预措施: 0.2% Hyaluronic acid gel (Drug)
0.8% Hyaluronic acid gel
0.8% topical hyaluronic-acid gel was applied palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day
干预措施: 0.8% Hyaluronic acid gel (Drug)
结局指标
主要结局
Pain
时间窗: 21 days
Using a visual analog scale (0: No pain, 10: Severe pain)
次要结局
- Color match(42 days)
- Consistency(42 days)
- Epithelialisation(42 days)
- Burning Sensation(21 days)
