| CTRI Number |
CTRI/2026/01/100233 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To speed up orthodontic tooth movement |
|
Scientific Title of Study
|
Accelerating orthodontic tooth movement through Vpro device |
| 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 Adeel Ahmed Bajjad |
| Designation |
Reader |
| Affiliation |
Kothiwal dental college and research centre |
| Address |
Department of orthodontics and dentofacial orthopedics kothiwal dental college and research centre
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9086176256 |
| Fax |
|
| Email |
dr4dentist@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Adeel Ahmed Bajjad |
| Designation |
Reader |
| Affiliation |
Kothiwal dental college and research centre |
| Address |
Department of orthodontics and dentofacial orthopedics kothiwal dental college and research centre
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9086176256 |
| Fax |
|
| Email |
dr4dentist@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Adeel Ahmed Bajjad |
| Designation |
Reader |
| Affiliation |
Kothiwal dental college and research centre |
| Address |
Department of orthodontics and dentofacial orthopedics kothiwal dental college and research centre
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9086176256 |
| Fax |
|
| Email |
dr4dentist@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of orthodontics, kothiwal dental college and research centre, Moradabad, Uttar Pradesh, India- 244001 |
|
|
Primary Sponsor
|
| Name |
Dr Adeel Ahmed Bajjad |
| Address |
Department of orthodontics and dentofacial orthopedics kothiwal dental college and research centre, Moradabad, Uttar Pradesh- 244001 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Adeel Ahmed Bajjad |
Kothiwal dental college and research centre |
Department of Orthodontics and dentofacial Orthopedics, Ground floor.
Moradabad
UTTAR PRADESH |
9086176256
dr4dentist@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL REVIEW BOARD KOTHIWAL DENTAL COLLEGE AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Systemic healthy individuals undergoing orthodontic treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
a high speed vibrator device |
Instruction will be given to patient to use vibrator which is a high-frequency vibration device at home for five minutes a day for 4 months duration. |
| Comparator Agent |
Controlled group having orthodontic treatment without vibrator |
retraction of lower anteriors will be done by taking anchorage from temporary anchorage device for 4 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Subject with Angle’s Class I bimaxillary protrusion or Class II Div 1 malocclusion having maxillary incisor proclination requiring extraction of mandibular first premolars with mild crowding of less than 2 millimetre or well aligned arches and chronological ages ranged from 18 to 30 years alongwith presence of all teeth except third molars.
|
|
| ExclusionCriteria |
| Details |
Subjects with severe crowding and severe vertical and horizontal growth pattern and craniofacial syndromes like clefts and any periodontally compromised along with any prior history of orthodontic treatment. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in fractal bone dimension |
at base line and every after 1 month for 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| lower anterior retraction |
at base line and every after 1 month for 4 months |
|
|
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 4 |
|
Date of First Enrollment (India)
|
25/01/2026 |
| 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="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr4dentist@gmail.com].
- For how long will this data be available start date provided 02-07-2026 and end date provided 02-01-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This study is a split-mouth, single-center, randomized control trial with a equal allocation, A total of 40 patients with pubertal age of 18 to 30 years with Class I malocclusion who came to Department of Orthodontics and Dentofacial Orthopaedics for treatment and requires mandibular first premolar extraction will be taken for the study. The right and left side of the patient will be further divided into two groups (20 control and 20 experimental). In order to avoid bias resulting from interpersonal variations, the split-mouth design has been chosen. The study is an open labelled as both patients and investigators are not blinded. The outcome assessor will be blinded. After completing levelling and alignment, the retraction will be done on stainless steel wire by taking anchorage from temporary anchorage Device. Instruction will be given to patient to use Vibrating device, which is a high-frequency vibration device at home for five minutes a day. One side will be the controlled site and other side will be experimental. Intra oral peri apical radiograph of both the sides will be taken after every 1 month for 4 months to check the anatomical variation in trabeculae pattern. The rate of tooth movement will be checked by measuring the distance between distal tip of canines and mesial tip first molar. |