Pre- and Post- Vitamin D supplementation comparative evaluation of clinical parameters of oral submucous fibrosis.

Not yet recruiting

• Conditions: Oral submucous fibrosis,

• Registration Number: CTRI/2023/06/054288
• Lead Sponsor: Dr Raksha Jaiswal

Brief Summary

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.

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|**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).

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|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.

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|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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-05-25
• Study Start: 2023-06-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Participants with OSMF stage II.
• (Chandramani More 2011 classification) 2.
• Participants with Serum Vitamin D levels of 15-30 ng/ml.
• Participants willing for the study.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fibrosis	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.
Vitamin D supplementation is beneficial as an adjuvant in the treatment of Oral Submucous	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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital

🇮🇳Nagpur, MAHARASHTRA, India

Dr Raksha Jaiswal

Principal investigator

9561855082

rakshabjaiswal7@gmail.com