Pre- and post-treatment estimation of serum vitamin D levels and comparative evaluation of clinical parameters of oral submucous fibrosis: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Vitamin D supplementation is beneficial as an adjuvant in the treatment of Oral Submucous
研究概览
简要总结
Vitamin D deficiency is a contributing factor tothe increase in various diseases. To the best of my knowledge, there is a lackof literature regarding such type of study where a comparison has been made pre-andpost-treatment changes in clinical parameters of Oral Submucous Fibrosis afterthe vitamin D supplementation.
| Group A – 30 Patients with Vitamin D levels between 15-30 ng/ml will be given conventional treatment i.e., Lycopene 16 mg daily in two equally divided doses for 3 months + Benzydamine hydrochloride mouthwash 0.15% 3 times a day for 4 weeks. |
Group B – 30 Patients with Vitamin D levels between 15-30 ng/ml will be given conventional treatment as mentioned in Group A + Vitamin D supplementation (60,000 IU weekly for 8 weeks).
| Pre-treatment serum vitamin D level, burning sensation and interincisal mouth opening will be measured. Then burning sensation and interincisal mouth opening will be measured and recorded at baseline, 1st,2nd, and 3rd month. |
All the patients will be prescribed vitamin D supplementation under the guidance of a General Physician. In Group A, after 3months, those patients will be referred to General Physician for vitamin D supplementation.
| Post-treatment of Group B, their blood sample will be collected for estimating serum vitamin D levels to evaluate and compare changes in mouth opening and burning sensation. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants with OSMF stage II.
- •(Chandramani More 2011 classification)
- •Participants with Serum Vitamin D levels of 15-30 ng/ml.
- •Participants willing for the study.
排除标准
- •Participants with Hypertension, Diabetes Mellitus, and other systemic diseases.
- •Participants with a history of bone pathology.
- •Participants with Vitamin D supplementation.
- •Participants taking medications like corticosteroids and anticoagulants.
- •Strict Vegetarian.
- •Participants not willing for the study.
结局指标
主要结局
Vitamin D supplementation is beneficial as an adjuvant in the treatment of Oral Submucous
时间窗: Pre-treatment serum vitamin D level, interincisal mouth opening, burning sensation will be measured. These clinical parameters will be measured and recorded at baseline, 1st, 2nd, and 3rd month.
Fibrosis
时间窗: Pre-treatment serum vitamin D level, interincisal mouth opening, burning sensation will be measured. These clinical parameters will be measured and recorded at baseline, 1st, 2nd, and 3rd month.
次要结局
- Comparison of clinical parameters i.e interincisal mouth opening and burning sensation pre- and post- treatment with vitamin D supplementation in the management of Oral Submucous Fibrosis.(baseline, 1,2,3 month.)