A Randomized Controlled Trial to Measure Pain Perception Following De-Epithelized Free Gingival Graft Harvesting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Pain Assessment (0=No Pain to 10=Worst)
研究概览
简要总结
This randomized clinical comparative study will evaluate the postoperative pain following the FGG graft harvest procedure technique covered by four different methods for coverage of the palatal donor site.
详细描述
This study will compare the application of :
- hemostatic collagen sponge
- collagen sponge sealed with abio-adhesive material
- Platelet rich fibrin
- physical barrier (stent) on the palatal donor sites with the purpose of which one of these will result in least postoperative pain after epithelialized gingival graft (EGG) harvesting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English speaking
- •At least 18 years old- 70 years old
- •Must be a patient of the UAB Dental School
- •Able to read and understand informed consent document
- •Patients needing soft tissue graft with teeth that have miller class I or II recession (>=2mm) on the facial aspects
- •Presence of periodontally healthy teeth at the recipient site.
- •Ability of the participants to maintain good oral hygiene
- •Patient not pregnant or breastfeeding
- •Not taking medications known to cause gingival enlargement
排除标准
- •Non-English speaking
- •Less than 18 years old, older than 70 years old
- •Smokers/tobacco users
- •Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
- •Patients that have severe gingival recession (Miller class III and IV) or < 2 mm.
- •Presence of periodontal disease at the recipient site.
- •Poor oral hygiene
- •Patient pregnant or breastfeeding
- •Taking medications known to cause gingival enlargement
研究组 & 干预措施
Collagen Plug with sutures
Palatal wound will be protected with collagen plug and sutures.
干预措施: palatal wound will be cover with collagen and sutures (Diagnostic Test)
Platelet Rich Fibrin (PRF)
palatal wound will be protected with Platelet rich Fibrin
干预措施: palatal wound covered with platelet rich fibrin (Diagnostic Test)
Collagen Plug with Cyanoacrylate (CPC)
Palatal wound will consist of collagen protection with the additional layer of cyanoacrylate surgical glue.
干预措施: palatal wound covered with a collagen sponge and cyanoacrylate (Diagnostic Test)
Palatal Stent
Palatal wound will be protected with palatal stent.
干预措施: palatal wound covered with a stent (Diagnostic Test)
结局指标
主要结局
Pain Assessment (0=No Pain to 10=Worst)
时间窗: day 14
To assess the pain outcomes using the visual analog scale from 0=No pain to 10=worst, excrutiating pain. Assessed daily from days 1 to 14, Day 14 reported.
Bleeding Assessment
时间窗: day 14
To assessed the bleeding outcomes using the visual analog scale (VAS) from 0=No bruising/bleeding to 10=severe bruising/bleeding. Assessed daily from days 1 to 14, Day 14 reported.
次要结局
- The Need for Painkiller(day 14)
- Activity Tolerance(day 14)
- Amount of Swelling(day 14)
研究者
Hussein Basma
Principal Investigator
University of Alabama at Birmingham