Clinical Comparison of MEBO Ointment and Hyaluronic Acid Gel in the Management of Pain After Free Gingival Graft Harvesting: A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 主要终点
- Post operative pain: VAS
研究概览
简要总结
Postoperative pain as well as bleeding are the most common complications after palatal graft harvesting also postsurgical swelling have been reported , Although different agents were used to protect the denuded areas on the palate as gelatin sponge , platelet rich fibrin (PRF) , medicinal plant extract (MPE) and platelet concentrate , no gold standard can be specified for this purpose
PICO Format:
P: Patients with mucogingival defects that require free gingival graft. I:1. Hyaluronic acid gel 0.2% placed in the palatal donor site then covered with periodontal pack (test group I) 2.MEBO ointment placed in the palatal donor site then covered with periodontal pack (test group II) C: Periodontal pack only O: Post-operative pain T: day 3, 7, 14, 21 and 42 postoperative.
Aim of the study:
To compare the effect of MEBO ointment versus Hyaluronic acid gel 0.2% applied to palatal donor site in post-operative pain reduction after free gingival graft harvesting.
Research question:
Is MEBO ointment as effective as hyaluronic acid gel in the management of postoperative pain after free gingival graft harvesting in the management of mucogingival defects?
详细描述
Interventions:
- Hyaluronic acid gel 0.2%
- MEBO ointment
Procedure:
The palatal sites will 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 previously 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.
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
- •Systemically healthy
排除标准
- •Occlusal trauma at site of graft
- •Pregnancy and lactation
- •Patients allergic to the used agents
- •Severe gagging reflex
研究组 & 干预措施
test group Hyaluronic acid
Patients scheduled for free gingival graft harvesting will receive Hyaluronic acid gel 0.2%
干预措施: Hyaluronic Acid gel (Drug)
test group MEBO ointment
Patients scheduled for free gingival graft harvesting will receive MEBO ointment
干预措施: MEBO ointment (Drug)
结局指标
主要结局
Post operative pain: VAS
时间窗: on day 7
measured by Visual analogue scale between 0 and 10. (0: no pain, 1: minimal pain, 5:moderate pain, 10: severe pain )
次要结局
- wound size(at day 21)
- Color match(On day 42)
研究者
Ahmed Mohamed Ahmed Hassan
postgraduate student
Cairo University