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CTRI Number  CTRI/2025/12/099996 [Registered on: 31/12/2025] Trial Registered Prospectively
Last Modified On: 29/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry
Other (Specify) [low magnitude high frequency vibrations are to be given]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to see if using small vibrating devices can speed up the closing of spaces when the upper teeth are pulled back with braces 
Scientific Title of Study   Assessment of high frequency vibrations on rate of space closure during Maxillary en-masse retraction: A Randomised Controlled 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  Ishaan Vasishta 
Designation  post graduate student 
Affiliation  Subharti Dental College 
Address  Deptt of Orthodontics and Dentofacial Orthopedics (room No. 7), Subharti Dental College, Swami Vivekanand Subharti University Subharti Puram, NH-58, Delhi Haridwar, NH58, Meerut, Uttar Pradesh
Deptt of Orthodontics and Dentofacial Orthopedics (room No. 7), Subharti Dental College, Swami Vivekanand Subharti University Subharti Puram, NH-58, Delhi Haridwar, NH58, Meerut, Uttar Pradesh 250002
Meerut
UTTAR PRADESH
250002
India 
Phone  9417997711  
Fax    
Email  ishaan.vasishta@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amit Kumar Khera 
Designation  Professor 
Affiliation  Subharti Dental College 
Address  Deptt of Orthodontics and Dentofacial Orthopedics (room No. 7), Subharti Dental College, Swami Vivekanand Subharti University Subharti Puram, NH-58, Delhi Haridwar, NH58, Meerut, Uttar Pradesh

Meerut
UTTAR PRADESH
250002
India 
Phone  8057143083  
Fax    
Email  dramitkkhera@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amit Kumar Khera 
Designation  Professor 
Affiliation  Subharti Dental College 
Address  Deptt of Orthodontics and Dentofacial Orthopedics (room No. 7), Subharti Dental College, Swami Vivekanand Subharti University Subharti Puram, NH-58, Delhi Haridwar, NH58, Meerut, Uttar Pradesh

Meerut
UTTAR PRADESH
250002
India 
Phone  8057143083  
Fax    
Email  dramitkkhera@gmail.com  
 
Source of Monetary or Material Support  
Deptt of Orthodontics and Dentofacial Orthopedics, Subharti Dental College, Swami Vivekanand Subharti University Subharti Puram, NH-58, Delhi Haridwar, NH58, Meerut, Uttar Pradesh 
 
Primary Sponsor  
Name  Dr. Ishaan Vasishta 
Address  Deptt of Orthodontics and Dentofacial Orthopedics, Subharti Dental College, Swami Vivekanand Subharti University Subharti Puram, NH-58, Delhi Haridwar, NH58, Meerut, Uttar Pradesh 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ishaan Vasishta  Subharti Dental College  Deptt. of Orthodontics and Dentofacial Orthopedics, Swami Vivekanand Subharti University Subharti Puram, NH-58, Delhi Haridwar, NH58, Meerut, Uttar Pradesh Swami Vivekanand Subharti University Subharti Puram, NH-58, Delhi Haridwar, NH58, Meerut, Uttar Pradesh 250002
Meerut
UTTAR PRADESH 
9417997711

ishaan.vasishta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
UNIVERSITY ETHICS COMMITTEE (Medical), SWAMI VIVEKANAND SUBHARTI UNIVERSITY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients who are undergoing orthodontic treatment and have reached the stage in which their en-masse retraction has to be started after levelling and alignment 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group 1 For enmasse retraction, Low Magnitude High Frequency Vibrations (120Hz) will be given.  To evaluate the rate of orthodontic tooth movement using high frequency vibrations from a high frequency vibratory device during en masse retraction of anterior six teeth with conventional MBT Bracket system after extraction of upper 1st premolars till closure of space ie. duration of about 6 months 
Comparator Agent  Group 2 For enmasse retraction, No supplemental vibrations will be given  No additional intervention is to given here 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1) Extraction of upper first premolars on both sides
2) Not more than 2-3mm of crowding should be present in the maxillary arch
3) Periodontally sound dentition
4) Good general health and not under any medication for any systemic disease
 
 
ExclusionCriteria 
Details  1) Non –compliance patient.
2) Patients with a history of parafunctional habits.
3) Patients with poor oral health.
4) Orthognathic surgery as treatment plan;
5) Previous history of orthodontic therapy 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Compare the effect of high frequency mechanical vibrations with that of conventional orthodontic treatment for en-masse retraction  around 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1) pain perception will be recorded using the VAS Scale, and 2) anterior root resorption will be measured on digital OPG using IC Measure software.  around 6 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 2 
Date of First Enrollment (India)   10/01/2026 
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="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  

Orthodontic treatment often takes a long time, discouraging many patients. To shorten treatment duration, researchers have explored methods to accelerate tooth movement, which are broadly classified as invasive (e.g., corticotomy, micro-osteoperforations, distraction procedures) and non-invasive techniques. Because invasive methods involve higher risks and discomfort, non-invasive approaches—such as low-energy lasers, electric/magnetic stimulation, and especially vibrational devices—are more widely investigated. Vibrations are believed to speed up tooth movement by stimulating bone remodelling. Animal studies (Nishiyama, Nishimura) have shown that especially high-frequency vibrations can increase cellular activity, promote osteocyte response, and enhance RANKL expression, leading to faster bone turnover. Commercial vibratory devices now exist, producing frequencies from 30–120 Hz (e.g., AcceleDent 30 Hz, VPro5 120 Hz). However, research results remain mixed. Some systematic reviews report little or no significant acceleration, while others find that low-frequency vibrations around 30 Hz may be beneficial. More recent studies have shifted focus to high-frequency vibrations. Animal studies (Alikhani, Takano-Yamamoto) and human trials using aligners (Shipley, Alansari) suggest high-frequency vibration may speed up tooth movement. High-frequency toothbrush use has also shown increased inflammatory mediators linked to faster movement. In contrast, low-frequency vibration studies, such as by Kumar et al., showed no significant benefit during en-masse retraction. Since there is limited research specifically on high-frequency vibrations during en-masse retraction, the purpose of the present trial is to evaluate whether high-frequency vibratory devices can effectively increase the rate of tooth movement in patients undergoing fixed orthodontic treatment

 
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