| CTRI Number |
CTRI/2024/11/076903 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
09/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The effect of taking Vitamin D on braces treatment speed in persons with less vitamin D in their body |
|
Scientific Title of Study
|
The effect of Systemic Administration of Cholecalciferol on the Rate of Orthodontic Tooth Movement of Maxillary Canines among subjects with Vitamin D deficiency- A Randomized Control 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 Akhilesh Singhal |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Room No. 208, First floor, Unit of Orthodontics and Dentofacial Orthopaedics, Oral Health Sciences Centre, PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9643350020 |
| Fax |
|
| Email |
akhileshsinghal@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S P Singh |
| Designation |
Professor & Head, Unit of Orthodontics |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Room No. 205, First floor, Unit of Orthodontics and Dentofacial Orthopaedics, Oral Health Sciences Centre, PGIMER, Sector 12, Chandigarh
Sector-12 Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815933748 |
| Fax |
|
| Email |
drspsingh_chd@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akhilesh Singhal |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Room No. 208, First floor, Unit of Orthodontics and Dentofacial Orthopaedics, Oral Health Sciences Centre, PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09643350020 |
| Fax |
|
| Email |
akhileshsinghal@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh
India
PIN: 160012 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research |
| Address |
Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh
India PIN- 160012 |
| Type of Sponsor |
Government medical college |
|
|
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 Akhilesh Singhal |
Post Graduate Institute of Medical Education and Research, Chandigarh |
Room No. 208, First floor, Unit of Orthodontics and Dentofacial Orthopaedics, Oral Health Sciences Centre, PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH |
09643350020
akhileshsinghal@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute of Medical Education and Research, Chandigarh Institutional Ethics Committee (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group, Group with No vitamin D supplements |
No vitamin D supplements will be given in this group. |
| Intervention |
Experimental Group, Vitamin D group |
the patients who were given Cholecalciferol sachet to normalize (30ng/ml) the serum Vitamin D levels (Dose consultation was done from Consultant of Endocrinology Department, PGIMER Chandigarh) |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients planned to be treated with fixed orthodontic treatment following maxillary first premolars extraction
2. Patients with Class I, Class II and Class III malocclusion
3. Deficient serum Vitamin D level (5-29.9 ng/ml)
4. Patients with full set of permanent teeth in maxillary arch
5. Age Group: 12-25 years
|
|
| ExclusionCriteria |
| Details |
1. Patients with severely deficient vitamin D level (≤5 ng/ml)
2. Patients with any malocclusion treated with non-extraction or extraction of teeth other than first premolars in maxillary arch
3. Patients with Cranio-facial syndromes and Cleft lip and palate
4. Patients with severe crowding or blocked out maxillary canines.
5. Patients already on Vitamin D supplements
6. Patients with liver, kidney, thyroid and parathyroid disorders.
7. Orthodontic retreatment cases
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of tooth movement (Maxillary Canine distal movement) |
T0- At start of canine retraction
T1- Three months after start of canine retraction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mesial movement of molar |
T0- At start of canine retraction
T1- Three months after start of canine retraction |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1 |
|
Date of First Enrollment (India)
|
25/11/2024 |
| 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="0"
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
|
The
effect of vitamin D supplements on rate of tooth movement (canine retraction)
has not been evaluated in humans in previous studies. Hence this randomized
clinical controlled trial is proposed to evaluate the
effect of vitamin D supplementation in vitamin D deficient subjects on amount
of orthodontic tooth movement during canine retraction phase of fixed
orthodontic therapy.Null hypothesis states
that there is no effect of cholecalciferol on the rate of orthodontic tooth
movement during canine retraction phase among subjects with vitamin D deficiency.
|