| CTRI Number |
CTRI/2025/12/098969 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry
Other (Specify) [vibratory device for accelerated orthodontics] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to check if vibratory stimulation can make braces work faster in children with different jaw growth patterns |
|
Scientific Title of Study
|
Influence of multi-frequency vibratory stimulation on rate of tooth movement in different facial growth patterns – a randomized controlled 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 Aravind Kumar Subramanian |
| Designation |
Professor and Head, Department of Orthodontics and Dentofacial Orthopaedics |
| Affiliation |
Saveetha Dental College and Hospital, Chennai |
| Address |
Saveetha Dental College, Departement of Orthodontics, Clinic 27
162, Poonamallee high road
Chennai-600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9841299939 |
| Fax |
|
| Email |
aravindkumar@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aravind Kumar Subramanian |
| Designation |
Professor and Head, Department of Orthodontics and Dentofacial Orthopaedics |
| Affiliation |
Saveetha Dental College and Hospital, Chennai |
| Address |
Saveetha Dental College
162, Poonamallee high road
Chennai-600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9841299939 |
| Fax |
|
| Email |
aravindkumar@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rishika Singla |
| Designation |
Resident |
| Affiliation |
Saveetha Dental College and Hospital, Chennai |
| Address |
Saveetha Dental College, Departement of Orthodontics, Clinic 27
162, Poonamallee high road
Chennai-600077
Chennai
TAMIL NADU
600077
India |
| Phone |
09810803406 |
| Fax |
|
| Email |
152308002.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rishika Singla |
| Address |
162, Poonamallee high road |
| Type of Sponsor |
Other [Myself] |
|
|
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 |
| Rishika Singla |
Saveetha Dental College and Hospital |
Department of Orthodontics, Clinic 27, 162, Poonamallee high road, Chennai - 600077
Chennai
TAMIL NADU |
09810803406
152308002.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College- Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients with bimaxillary protrusion or upper dental proclination requiring upper first premolar extraction during orthodontic treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
vibratory force |
110 Hz vibratory frequency |
| Intervention |
vibratory force |
130 Hz vibratory frequency |
| Intervention |
vibratory force |
90 Hz vibratory frequency |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients with bilateral upper 1st premolar extractions are included.
Patients with maxillary protrusion with minimal or no crowding. |
|
| ExclusionCriteria |
| Details |
Patients with periodontal problems.
Patients with poor oral hygiene.
Patients having systemic diseases. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
rate of tooth movement
|
T0 - start of retraction
T3 - after 3 months of retraction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pain or discomfort using VAS scale |
day 1 of using device
day 3 of using device
|
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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)
|
22/12/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
It is a randomized controlled clinical trial in which orthodontic patients undergoing upper first premolar extraction are divided into 3 groups based on frequency of vibratory force (n=18) - Group 1 - 90 Hz (n=6) Group 2 - 110 Hz (n=6) Group 3 - 130 Hz (n=6)
All 3 frequencies are tested in Horizontal (n=3 in each group) and Vertical (n=3 in each group) growth pattern patients to check whether the acceleration of tooth movement varies with the facial growth pattern of an individual.
To check the rate of tooth movement, intra oral scans of the patients are taken at the start of retraction (T0) and after 3 months of completing retraction (T3)
Pain / discomfort scores are also assessed using VAS scale. |