Clinical Comparison of the Use of Flowable Resin Composite Stent Versus Periodontal Pack to Reduce Donor Site Morbidity After 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
- 34
- 试验地点
- 2
- 主要终点
- Post operative pain
研究概览
简要总结
After harvesting free gingival graft from the hard palate, Postoperative pain as well as bleeding are the most common complications.Different agents were used to protect the denuded areas on the palate as gelatin sponge, Hyaluronic acid gel and platelet rich fibrin (PRF) but still no gold standard material is present.
PICO format:
P: patients with mucogingival problems in need for free gingival graft or de-epithelialized connective tissue graft.I: Flowable resin composite stent. C: Periodontal pack. O: Post-operative pain T: day 3, 7, 14, 21 and 42 postoperative.
Aim of the study:
To compare the effect of flowable composite stent versus periodontal pack applied to palatal donor site after free gingival graft harvesting in terms of post-operative pain reduction.
详细描述
Intervention:
Flowable resin composite stent.
Procedure:
After the palatal sites be anaesthetized with 0.3 ml of a solution of 4% Articaine and 0.001% Adrenalin. Graft harvesting will be performed by basic surgical techniques described by Miller (1982). A rectangular shaped piece of mucosa will be harvested from the area of the hard palate by a split-thickness dissection.
The graft will then be used as it on the recipient bed. The graft dimensions will be recorded (width and length).
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)
入排标准
- 年龄范围
- 21 Years 至 62 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with mucogingival defects scheduled for free gingival graft or de-epithelialized connective tissue graft.
- •Systemically healthy
排除标准
- •Occlusal trauma at site of graft
- •Pregnancy and lactation
- •Patients allergic to the used agents
- •Severe gagging reflex
结局指标
主要结局
Post operative pain
时间窗: on day 7
Pain score reported by the patient directly through Visual Analogue Scale score (between 0 and 100. 0: no pain, 10: minimal pain, 50:moderate pain, 100: severe pain)
次要结局
- Color match(On day 42)
- wound size(at day 21)
研究者
Mohamed Elsayed Ahmed Hassan Temraz
demonstrator
Cairo University