A comparative analysis of intralesional therapy and diode laser therapy in the management of oral submucous fibrosis – A split mouth approach
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Comparison of pre operative and post operative mouth opening
研究概览
简要总结
This study is designed to compare the intralesional injections (Dexamethasone and Hyaluronidase) and diode lasers in the management of Oral Submucous Fibrosis patients. The objectives of this study is to assess pre-operative and post-operative mouth opening,cheek flexibility,burning sensation and blanching of buccal mucosa. A total of 19 patients were included. After obtaining informed conset, flip coin method was used to select the side of the cheek for intralesional injections ( total of 8 doses biweekly 2 doses for about 4 week will be performed ) in the middle of 2 week after 4 dose of intralesional injection, laser fibrotomy was performed by using diode lasers. After 4 weeks pre and postoperative assessement of out comes were assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •patients with bilateral palpable fibrous bands
- •patients with burning sensation
- •patients with blanching of oral mucosa
- •patients with restricted mouth opening.
排除标准
- •Patients who had received or undergoing treatment
- •Patients who were medically compromised
- •Patients who are not willing for treatment
- •Patients who are not willing to participate in study after the explanation of the procedure.
结局指标
主要结局
Comparison of pre operative and post operative mouth opening
时间窗: 4 weeks
次要结局
- Resilience of cheek(Burning sensation)
研究者
DrTRamesh
Vishnu Dental College