Comparison of Abdominal Dermal Fat Graft with Nasolabial Flap as Graft in Surgical Management of Advanced Oral Submucous Fibrosis- A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Interincisal mouth opening
研究概览
简要总结
Oral Submucous fibrosis is a debilitating but preventable oral disease, which affects mouth opening and general health condition of the patient. The various treatment modalities are mainly medical, surgical, or a combination of both. The goal of this study is to find a promising graft material in the form of abdominal dermal fat graft and compare it with conventional nasolabial flap being used as graft in the management of advanced oral submucous fibrosis, in terms of - Interincisal mouth opening, Graft uptake, Lower facial height, Donor site morbidity, Surgical time of the procedure, Quality of life and Ease of surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 17.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with OSMF Grade 3 and 4A
- •Patients in whom diagnosis is confirmed clinically
- •Patient with mouth opening equal to or less than 15mm.
- •Good general health status.
- •Patient with good oral hygiene and motivation.
排除标准
- •Patients with OSMF Grade 1, 2 and 4B
- •Patients with presentation of any other cause of trismus.
- •Medically compromised patients (ASA class III and IV)
- •Not willing to quit deleterious habits.
结局指标
主要结局
Interincisal mouth opening
时间窗: preoperatively, and | postoperatively and at 6 months
次要结局
- Donor site morbidity
- Surgical time of the procedure(from first incision till the placement of last suture)
- Graft uptake
- Lower facial height(preoperatively and post operatively at 6 months)
- Quality of life(preoperatively and)
- Ease of surgery(postoperatively)
研究者
Dr Mehak Kataria
Government Dental College and Hospital, Nagpur