Efficacy of Resveratrol-Based Gel Versus Hyaluronic Acid Gel as a Palatal Wound Dressing Materials on Postoperative Pain Following Free Gingival Graft Surgery: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Postoperative Pain
研究概览
简要总结
Aim of the study to compare the effect of Resveratrol- Based gel versus 0.2% Hyaluronic acid gel applied to the palatal donor site and acrylic resin stent only in post-operative pain reduction after free gingival graft harvesting.
详细描述
Treatment Protocol Presurgical Phase Initial phase will involve comprehensive periodontal treatment, including full mouth supragingival scaling, subgingival debridement using ultrasonic devices and Gracey curettes, and polishing one month prior to surgery. Patients will receive detailed instructions on mechanical plaque control techniques, such as the brushing technique with a soft toothbrush, and the importance of maintaining oral health.
Additionally, 0.12% Chlorhexidine HCL mouthwash will be prescribed for chemical plaque control, to be used twice daily for 2 weeks.
Surgical procedure Step 1: Preparing the recipient site. Step 2: Harvesting the free gingival graft from palate. The Free Gingival Graft (FGG) will be harvested from the palate using a standardized technique. The palatal sites will be anaesthetized with a solution of 2% lidocaine and 0.001% adrenaline. A partial thickness graft, consisting of epithelium and a thin layer of connective tissue, will be harvested with proper thickness between 1.0 and 1.5 mm for optimal graft survival.
Step 3: Placement of free gingival graft on the recipient beds Step 4: Management of the Palatal Wound
Denuded palatal area will be protected using one of the following options:
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, Care Provider, Outcomes Assessor)
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
- •Patient over 18 years of age
- •Systemically healthy
- •Plaque index (PI) and gingival index (GI) less than 15% (Silness & Löe)
- •Patients with Mucogingival defects scheduled for free gingival graft
排除标准
- •Pregnancy or breastfeeding.
- •Occlusal trauma at site of graft.
- •Severe gagging reflex
- •Patients allergic to the used materials.
研究组 & 干预措施
Resveratrol-Based gel
The Resveratrol-Based gel will be applied using a sterile plastic syringe, and the palatal wound will be immediately covered by an acrylic resin stent. Three days postoperatively, the patients will be recalled, the stent will be removed for evaluation and the Resveratrol gel will be reapplied.
干预措施: Resveratrol-Based gel (Drug)
Hyaluronic acid gel 0.2%
0.2% hyaluronic acid gel (Gengigel®) The 0.2% Hyaluronic acid gel will be applied using a sterile plastic syringe, and the palatal wound will be covered by an acrylic resin stent. Three days postoperatively, the patients will be recalled, the stent will be removed for evaluation, and the Hyaluronic acid gel will be reapplied.
干预措施: Hyaluronic acid gel 0.2% (Drug)
Acrylic resin stent only.
The palatal donor site covered with acrylic resin stent only.
干预措施: Stent (Device)
结局指标
主要结局
Postoperative Pain
时间窗: at (0--7 days)
direct measure by using Visual Analog Scale (VAS) pain scores (ranging from 0 to 10, where 0 indicates no pain 1: minimal pain and 10 signifies severe pain) will be recorded daily for one week as the pain is expected to reach its maximum level during the initial healing phase (0-3 days)
次要结局
- Color match..(on day 3, day 7, day 14, day 21, and day 42)
- Indirect Postoperative Pain by analgesic consumption consumption Postoperative(at (0-7) days)
- Wound size(at surgery day, day 3, day 7, day 14 and day 21)
- patient satisfaction with the healing process(completed 1 week after the surgery)
研究者
Liza saleh kasem ALhakam
Dentist
Cairo University