Clinical Effectiveness of Oral Wound Dressing (Ora-Aid) in Comparison to Palatal Stent in Management of Postoperative Pain Following Free Gingival Graft Harvesting: A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Postoperative Pain
研究概览
简要总结
This randomized clinical trial evaluates the effectiveness of Ora-Aid oral wound dressing compared to an acrylic palatal stent in managing postoperative pain following free gingival graft harvesting. Patients undergoing graft harvesting will be randomly assigned to receive either Ora-Aid dressing or a palatal stent at the donor site. The primary outcome is postoperative pain assessed using the Visual Analogue Scale (VAS). Secondary outcomes include analgesic consumption, wound size, patient satisfaction, and color match over a 42-day follow-up period.
详细描述
Free gingival graft (FGG) harvesting is a commonly used periodontal procedure, but it is associated with significant postoperative pain and discomfort at the palatal donor site. Traditional management using acrylic palatal stents provides mechanical protection but may interfere with patient comfort and oral function.
Ora-Aid is a bio-adhesive hydrogel-based wound dressing designed for intraoral use, providing protection, reducing mechanical irritation, and potentially enhancing healing. Despite promising results in previous studies, there is limited evidence from randomized controlled trials comparing Ora-Aid with conventional palatal stents.
This study is a randomized, parallel-group clinical trial designed to compare the effectiveness of Ora-Aid and acrylic palatal stents in managing postoperative pain following FGG harvesting. Patients will be randomly allocated in a 1:1 ratio to either intervention group.
Pain will be assessed using the Visual Analogue Scale (VAS), while secondary outcomes include analgesic consumption, wound size, patient satisfaction, and color match at multiple postoperative time points (3, 7, 14, 21, and 42 days).
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 (Outcomes Assessor)
盲法说明
The operator (investigator performing the surgical procedure) and participants cannot be blinded due to the nature of the interventions (visible difference between Ora-Aid wound dressing and palatal stent). However, the outcomes assessor (co-supervisor) who evaluates all primary and secondary outcomes will be blinded to the treatment group assignment. The biostatistician analyzing the data will also be blinded to group allocation.
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 over 18 years of age
- •Systemically healthy
- •Patients with good oral hygiene
- •Patients with mucogingival defects scheduled for free gingival graft (FGG)
排除标准
- •Pregnancy or breastfeeding
- •Severe gagging reflex
- •Patients allergic to the materials used in the study
研究组 & 干预措施
Palatal Stent
Participants in this arm will receive an acrylic resin palatal stent to cover the palatal donor site immediately after free gingival graft harvesting. The stent will be fabricated using alginate impression with two Adams clasps and wax relief between the canine and second molar to accommodate gauze placement. The stent will be retained for two weeks and removed at day 3 for wound evaluation before being replaced.
干预措施: Acrylic Resin Palatal Stent (Device)
Ora-Aid Oral Wound Dressing
Ora-Aid is a hydrogel-based, bioadhesive wound dressing designed for intraoral application. After harvesting the free gingival graft and managing hemostasis at the palatal donor site, the Ora-Aid patch will be cut and adjusted to fit the wound size. The dressing will be applied directly to the palatal wound and pressed gently for 10 seconds to aid adherence. It will then be fixed using 5/0 proline suture with a slinged horizontal figure-eight suture technique. The dressing provides a physical barrier over the wound, preventing mechanical irritation and reducing pain. Reapplication will occur every 3-5 days as needed until complete epithelialization is achieved (typically 10-14 days). The adhesive integrity of Ora-Aid typically lasts up to 72 hours.
干预措施: Ora-Aid Oral Wound Dressing (Other)
结局指标
主要结局
Postoperative Pain
时间窗: Days 1, 2, 3, 4, 5, 6, and 7 postoperatively
Postoperative pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates no pain, 1 indicates minimal pain, and 10 signifies severe pain. Patients will record their pain scores daily during the initial healing phase when pain is expected to be at its maximum level.
次要结局
- Analgesic Consumption(Daily for 7 days postoperatively)
- Wound Size(Day 0 (surgery day), Day 3, Day 7, Day 14, and Day 21)
- Patient Satisfaction with Healing Process(1 week (Day 7) postoperatively)
- Color Match of Palatal Mucosa(Day 3, Day 7, Day 14, Day 21, and Day 42 postoperatively)
研究者
Ahmed Sabry
Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University
Cairo University