| CTRI Number |
CTRI/2025/02/080685 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to see the effects of vitamin D3 in increasing the orthodontic tooth movement. |
|
Scientific Title of Study
|
Evaluation of the effect of local administration of vitamin D3 on the maxillary canine retraction and the amount of external apical root resorption: A Prospective, Double blind, Split mouth randomized control clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DEVYANSHU SHARMA |
| Designation |
Postgraduate student |
| Affiliation |
Department of Orthodontics and Dentofacial Orthopedics,Bhojia Dental College and Hospital,Baddi, Dist. Solan, Himachal Pradesh 173205, India |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, Bhojia Dental College and Hospital, Baddi, Dist. Solan, HIMACHAL PRADESH 173205, INDIA
Department of Orthodontics and Dentofacial Orthopedics, Bhojia Dental College and Hospital, Baddi, Dist. Solan, HIMACHAL PRADESH 173205, INDIA
Solan
HIMACHAL PRADESH
173205
India |
| Phone |
7986387321 |
| Fax |
|
| Email |
sdevyanshu023@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Mittal |
| Designation |
Professor and Head |
| Affiliation |
Bhojia Dental College and Hopsital, Baddi, H.P. |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, Bhojia Dental College and Hospital, Baddi, Dist. Solan, HIMACHAL PRADESH 173205, INDIA
Solan
HIMACHAL PRADESH
173205
India |
| Phone |
09896050995 |
| Fax |
|
| Email |
sanjaymtdr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DEVYANSHU SHARMA |
| Designation |
Postgraduate student |
| Affiliation |
post graduate student |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, Bhojia Dental College and Hospital, Baddi, Dist. Solan, HIMACHAL PRADESH 173205, INDIA
Department of Orthodontics and Dentofacial Orthopedics, Bhojia Dental College and Hospital, Baddi, Dist. Solan, HIMACHAL PRADESH 173205, INDIA
Solan
HIMACHAL PRADESH
173205
India |
| Phone |
09896050995 |
| Fax |
|
| Email |
sdevyanshu023@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics and Dentofacial Orthopedics, Bhojia Dental College and Hospital, Baddi, Dist. Solan, HIMACHAL PRADESH 173205, INDIA |
|
|
Primary Sponsor
|
| Name |
DEVYANSHU SHARMA |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, Bhojia Dental College and Hospital, Baddi, Dist. Solan, HIMACHAL PRADESH 173205, INDIA |
| 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 Devyanshu Sharma |
Department of Orthodontics and Dentofacial Orthopedics,Bhojia Dental College and Hospital |
Room no. 4, Department of Orthodontics and Dentofacial Orthopedics,Bhojia Dental College and Hospital, Baddi, Dist. Solan
Solan
HIMACHAL PRADESH |
7986387321
sdevyanshu023@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Bhojia Dental College and Hospital, Bhud, Baddi (H.P.) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Medically fit |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Placebo |
| Intervention |
Vitamin D3 intraligamentary injection |
A dose of 45 pg Vitamin D3 per 0.1 mL of Lignocaine periodontal (intraligamentary) injection will be given on the experimental side in the distal side of canine on monthly basis for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Males and females
Age range 15-30 years
Critical anchorage
Class I Bi-maxillary protrusion cases and Class II Div 1 malocclusion cases with ANB less than 5 degrees.
Good gingival and periodontal health (probing depth Good gingival and periodontal health (probing depth less than or equal to 3mm, gingival index score less than or equal to 1, plaque index less than or equal to 1)
No systemic disease.
Patients requiring bilateral extraction of maxillary 1st premolar as part of their comprehensive treatment.
No endodontic lesions
No dilaceration of canine roots as assessed on pre-treatment OPG
No radiographic evidence of bone loss
No history of periodontal therapy
No current active periodontal disease
Full development of teeth except 3rdmolars.
|
|
| ExclusionCriteria |
| Details |
Subjects with known hepatic or renal disease,
Metabolic bone disease,
History of allergy or autoimmune disease,
Malabsorption,
Type 1 diabetes,
Hypercortisolism,
Malignancy,
Immobility for more than 1 week,
Pregnancy, lactation,
Medications influencing bone metabolism and any chronic consumption of anti inflammatory drug calcium, Vitamin D, calcium, and also fish oil supplement
History of sun bathing after starting the orthodontic treatment
Whose radiographs lacked visibility of upper incisors,
Those with significantly distorted radiographs, crowding of teeth, unclear roots, and those with unilaterally and bilaterally lateral missing teeth in the maxilla.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The predictor variable is the canine retraction technique i.e. canine retraction with and without Vitamin D3 injection. The canine retraction is our primary outcome. |
Base time point is TO, then every monthly time point till four months i.e. T1, T2, T3, T4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Canine Rotations, external apical root resorption and molar rotations will be measured at monthly time intervals till 4 months from the base time point. |
Base time point is TO, then every monthly time point till four months i.e. T1, T2, T3, T4 |
|
|
Target Sample Size
|
Total Sample Size="19"
Sample Size from India="19"
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)
|
28/02/2025 |
| 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="0"
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 study titled Evaluation of the Effect of Local Administration of Vitamin D3 on Maxillary Canine Retraction and External Apical Root Resorption is a prospective, double-blind, split-mouth, randomized controlled clinical trial. The primary objective is to assess the effect of intraligamentary Vitamin D3 injections on the rate of maxillary canine retraction. The trial will include patients undergoing orthodontic treatment that requires the retraction of maxillary canines. Each patient’s maxillary arch will be divided into experimental and control sides. The experimental side will receive Vitamin D3 injections which is diluted in lignocaine, while the control side will receive plain lignocaine. The study aims to determine whether Vitamin D3 can enhance the rate of tooth movement and reduce treatment duration, which is particularly beneficial for adult patients where bone metabolism is slower, leading to prolonged treatment durations. The study design ensures a high level of scientific rigor by using a randomized, double-blind approach, thereby reducing bias. Outcomes will be measured in terms of the rate of canine retraction, with regular follow-ups and measurements taken to ensure accurate results. This research could potentially lead to improved orthodontic treatment protocols, providing faster and more efficient outcomes for patients. The study will be conducted according to the 1975 Helsinki declaration guidelines revised in 2013. Statistical analysis will be done with SPSS version 22.0. |