| CTRI Number |
CTRI/2025/11/098078 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Study To Know the effect Of Vitamin D Tablets In Treating Oral Lichen planus In Adults |
|
Scientific Title of Study
|
The Effectiveness Of Vitamin D Supplementation In The Therapeutic Management of Oral Lichen Planus In Adults- A Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jeyapriya G |
| Designation |
Post Graduate Dept of Oral Medicine and Radiology |
| Affiliation |
Government Dental College Kozhikode |
| Address |
Government Dental College Medical College Campus
Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
09940652131 |
| Fax |
|
| Email |
jeya2000priya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nileena R Kumar |
| Designation |
Professor & Head, Dept of Oral Medicine and Radiology |
| Affiliation |
Government Dental College Kozhikode |
| Address |
Government Dental College Medical College Campus
Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
9446161819 |
| Fax |
|
| Email |
nileenark2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jeyapriya G |
| Designation |
Post Graduate Dept of Oral Medicine and Radiology |
| Affiliation |
Government Dental College Kozhikode |
| Address |
Government Dental College Medical College Campus
Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
09940652131 |
| Fax |
|
| Email |
jeya2000priya@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Board Of Medical Research, Medical College campus , Kozhikode , Kerala -673008 |
|
|
Primary Sponsor
|
| Name |
State Board Of Medical Research |
| Address |
Medical college campus , Kozhikode , Kerala -673008 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jeyapriya G |
Government Dental College |
Room No 7 Dept of Oral Medicine and Radiology
Kozhikode
KERALA |
9940652131
jeya2000priya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee , GDC Kozhikode |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: L438||Other lichen planus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
vitamin D Tablets |
Giving Vitamin D Supplementation as vitamin D tablet sachet of 4 tablets , 60000IU ,once a week for 4 weeks to both controls and cases on alternate months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged above 18 years, diagnosed with Oral Lichen Planus (OLP) based on the clinical and histopathological features and with serum vitamin D levels less than 30 ng per ml will be included in the study. |
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years
2. Current systemic steroid or immunosuppressive therapy for OLP
3. Oral lichenoid contact reactions caused by dental materials or lichenoid drug reactions
4. Pregnancy or lactation
5. Presence of any other oral mucosal lesions
6. Patients with diseases like Chronic renal disease and CVA and CAD
7. Debilitated patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Disease severity 1.Reduction using the ODSS( Oral Disease Severity Scale) and REU scoring system
2.Pain reduction using the VAS Scale |
outcome assessed at 2 weeks ,4weeks,6 weeks,8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a crossover non-randomized controlled trial
conducted at the Department of Oral Medicine and Radiology, Government Dental
College, Kozhikode, over 18 months. Patients aged 18 years and above with
histopathologically confirmed OLP and serum vitamin D levels below 30 ng/ml
will be included. Exclusion criteria include systemic immunosuppressive
therapy, pregnancy, and systemic comorbidities. Participants will be
categorized into Group A (less than 20 ng/ml) and Group B (20 to 29 ng/ml).
In Month 1, Group A receives vitamin D (60000 IU per week),
corticosteroids, and antioxidants; Group B receives corticosteroids and
antioxidants only.
In Month 2, a crossover occurs. Group B now receives vitamin
D, while Group A discontinues it. Follow-ups every two weeks will assess
disease severity using ODSS and REU scoring systems and pain using the VAS
scale.
Quality of life will be assessed before treatment and six
months after treatment using the 15-point COMDQ |