| 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
|
|
|
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
|
|
|
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 |