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

Pre- and post-treatment estimation of serum vitamin D levels and comparative evaluation of clinical parameters of oral submucous fibrosis: A Randomized Controlled Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/054288
Enrollment
60
Registered
2023-06-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K135- Oral submucous fibrosis

Interventions

Intervention1: Vitamin D: 60,000 IU once weekly for 8 weeks Intervention2: Vitamin D: 60,000 IU once weekly for 8 weeks Control Intervention1: Lycopene Benzydamine HCl 0.15%: Lycopene 16 mg daily in t

Sponsors

Dr Raksha Jaiswal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants with OSMF stage II. (Chandramani More 2011 classification) 2. Participants with Serum Vitamin D levels of 15-30 ng/ml. 3. Participants willing for the study.

Exclusion criteria

Exclusion criteria: 1. Participants with Hypertension, Diabetes Mellitus, and other systemic diseases. 2. Participants with a history of bone pathology. 3. Participants with Vitamin D supplementation. 4. Participants taking medications like corticosteroids and anticoagulants. 5. Strict Vegetarian. 6. Participants not willing for the study.

Design outcomes

Primary

MeasureTime frame
Vitamin D supplementation is beneficial as an adjuvant in the treatment of Oral Submucous FibrosisTimepoint: 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

MeasureTime frame
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.Timepoint: baseline, 1,2,3 month.—

Countries

India

Contacts

Public ContactDr Rakhi Chandak

Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Wanadongri, Nagpur.

rakshabjaiswal7@gmail.com09561855082

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026