Comparison of Triamcinolone With Pentoxifylline and Vitamin- E Efficacy in the Treatment of Stage 2 and 3 Oral Submucous Fibrosis: A Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Group 1: Triamcinolone measuring mouth opening using calibrated Vernier Caliper
研究概览
简要总结
To compare the efficacy of Triamcinolone with Pentoxifylline and Vitamin E in patients with stage two and three oral submucous fibrosis.
详细描述
To compare the efficacy of Triamcinolone with Pentoxifylline and Vitamin E in patients with stage two and three oral submucous fibrosis.
It was a randomized control clinical trial to compare efficacy of injection steroids versus pentoxifylline and vitamin E in the treatment of stage 2 and 3 OSF patient. Total 40 patients who presented with signs and symptoms of OSF were enrolled in our study that was evaluated over the period of (January 2020 to September 2021). Parameters taken in the study were age and mouth opening. Descriptive statistics and paired t-test were used for statistical analysis.
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 (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with clinically diagnosed OSMF who have not undergone any treatment of OSMF in past
- •Patients willing to quit their tobacco chewing habit, gutkha areca nut smoking
- •Patients who are ready to attend regular follow-ups
排除标准
- •Patients who have undergone any treatment for OSF in past
- •Patients with any evidence of cardiac, gastrointestinal, kidney, metabolic disorders, pregnant and lactating women's
- •Patients with any co-existing disorder of the orofacial region other than OSF which may interfere with the study protocol
研究组 & 干预措施
Group 1: Triamcinolone
Injection steroid Triamcinolone 400mg with lidocaine 1:1 was given twice a week for 4 weeks in bi-lateral buccal mucosa in multiple sites
干预措施: Triamcinolone (Drug)
Group 2: Pentoxifylline with Vitamin E
Pentoxifylline 40mg twice a day along with vitamin E supplement one tablet per day for 4 weeks
干预措施: Pentoxifylline with Vitamin E (Drug)
结局指标
主要结局
Group 1: Triamcinolone measuring mouth opening using calibrated Vernier Caliper
时间窗: 21 months
Measuring mouth opening measuring mouth opening using calibrated Vernier Caliper by recording in millimeters the maximum mouth opening
Group 2: Pentoxifylline with Vitamin E measuring mouth opening using calibrated Vernier Caliper
时间窗: 21 months
Measuring mouth opening measuring mouth opening using calibrated Vernier Caliper by recording in millimeters the maximum mouth opening
次要结局
未报告次要终点
研究者
Abhishek Lal
Dr. Abhishek Lal
Altamash Institute of Dental Medicine