Comparative study to evaluate the efficacy of turmizinc and point one percent triamcinolone acetonide oral paste in the treatment of oral submucous fibrosis A Randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Increase in mouth opening (interincisal distance)
研究概览
简要总结
AIM
To evaluate the efficacy of turmizinc vs 0.1 percentage triamcinolone acetonide in treatment of oral submucous fibrosis.
Objective
1. Evaluate improvement in burning sensation
2. Evaluate improvement in mouth opening
3. Evaluate improvement in elasticity of the mucosa
4. Evaluate improvement in tongue protrusion
5. Evaluate adverse effects of the therapy
Intervention group – Turmizinc
Comparator group – Triamcinolone acetonide 0.1%
Hypothesis
The null hypothesis (H0) is that there is no difference between the outcomes in turmizinc and triamcinolone acetonide oral paste in treatment of OSMF.
The alternate hypothesis (Ha) is that the efficacy of turmizinc is better when compared to triamcinolone acetonide in the treatment of OSMF.
Timeline for data collection—at baseline
7 days after intervention
15 days after intervention
30 days after intervention
60 days after intervention
The present study will be conducted in the Department of Oral Medicine and Radiology at DY Patil School of Dentistry, Navi Mumbai.
The sample size is decided to be 30, (n) with n1 being group 1 and n2 being group 2. Each group will have 15 participants.
The sample size for comparing two means was determined by the following formula using G*power software 3.1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with OSMF clinically and histopathologically.
- •Patients with age group: 18 yr.
- •Patients with OSMF Stage I and Stage II (More et al. classification 2011)
- •Patients who have not been treated previously for OSMF.
排除标准
- •Patients with other mucosal lesions other than OSMF
- •Patients with trismus due to other reasons.
- •Patients who have already been given or are currently on any treatment for OSMF
- •Patients with systemic ailments having OSMF.
结局指标
主要结局
Increase in mouth opening (interincisal distance)
时间窗: Increase in mouth opening (interincisal distance) | Reduction in burning sensation (VAS score) | Increase in tongue protrusion
Reduction in burning sensation (VAS score)
时间窗: Increase in mouth opening (interincisal distance) | Reduction in burning sensation (VAS score) | Increase in tongue protrusion
Increase in tongue protrusion which will be assessed at 7 day, 15 days, 30 days and 60 days from the start of treatment
时间窗: Increase in mouth opening (interincisal distance) | Reduction in burning sensation (VAS score) | Increase in tongue protrusion
次要结局
未报告次要终点
研究者
Dr Vagisha Choudhary
D Y Patil University School Of Dentistry