| CTRI Number |
CTRI/2023/06/054288 [Registered on: 21/06/2023] Trial Registered Prospectively |
| Last Modified On: |
25/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Pre- and Post- Vitamin D supplementation comparative evaluation of clinical parameters of oral submucous fibrosis. |
|
Scientific Title of Study
|
Pre- and post-treatment estimation of serum vitamin D levels and comparative evaluation of clinical parameters of oral submucous fibrosis: A Randomized Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raksha Jaiswal |
| Designation |
Post-graduate Student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Wanadongri, Nagpur. |
| Address |
Ground floor, Room no 3, Department of Oral Medicine and Radiology, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Wanadongri, Nagpur.
Nagpur
MAHARASHTRA
441110
India |
| Phone |
09561855082 |
| Fax |
|
| Email |
rakshabjaiswal7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raksha Jaiswal |
| Designation |
Post-graduate Student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Wanadongri, Nagpur. |
| Address |
Ground floor, Room no 3, Department of Oral Medicine and Radiology, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Wanadongri, Nagpur.
Nagpur
MAHARASHTRA
441110
India |
| Phone |
09561855082 |
| Fax |
|
| Email |
rakshabjaiswal7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakhi Chandak |
| Designation |
Reader, PG Guide |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College, Wanadongri, Nagpur |
| Address |
Ground Floor, Room No. 3, Department of Oral Medicine and Radiology, Swargiya Dadasaheb Kalmegh Smruti Dental College, Wanadongri, Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9011071465 |
| Fax |
|
| Email |
rakhi.chandak@sdk-dentalcollege.edu.in |
|
|
Source of Monetary or Material Support
|
| Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Wanadongri, Nagpur |
|
|
Primary Sponsor
|
| Name |
Dr Raksha Jaiswal |
| Address |
Ground Floor, Department of Oral Medicine and Radiology, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Wanadongri, Nagpur- 441110 |
| Type of Sponsor |
Other [Self] |
|
|
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 Raksha Jaiswal |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
Department of Oral Medicine and Radiology, Ground floor, Room no 3,Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Wanadongri, Nagpur- 441110
Nagpur
MAHARASHTRA |
9561855082
rakshabjaiswal7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K135||Oral submucous fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lycopene
Benzydamine HCl 0.15% |
Lycopene 16 mg daily in two equally divided doses for 3 months + Benzydamine
hydrochloride mouthwash 0.15% 3 times a day for 4 weeks.
|
| Intervention |
Vitamin D |
60,000 IU once weekly for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Vitamin D supplementation is beneficial as an adjuvant in the treatment of Oral Submucous
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. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/06/2023 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Vitamin D deficiency is a contributing factor to
the increase in various diseases. To the best of my knowledge, there is a lack
of literature regarding such type of study where a comparison has been made pre-and
post-treatment changes in clinical parameters of Oral Submucous Fibrosis after
the 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.
|
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