| CTRI Number |
CTRI/2025/07/090061 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
27/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study on Laser and Vibration Exposure in Participants for Retaining Results After Braces |
|
Scientific Title of Study
|
Comparative evaluation of low level laser therapy and high frequency vibrations on retention after fixed orthodontic treatment: a randomized 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 |
Dr Aakashdeep |
| Designation |
Post graduate student |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, NH 58, Delhi Haridwar Bypass Road
Meerut UTTAR PRADESH 250005 India |
| Phone |
8901154505 |
| Fax |
|
| Email |
aakashdeep0089@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Amit Kumar Khera |
| Designation |
Professor |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, NH 58, Delhi Haridwar Bypass Road
Meerut UTTAR PRADESH 250005 India |
| Phone |
8057143083 |
| Fax |
|
| Email |
dramitkkhera@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Aakashdeep |
| Designation |
Post graduate student |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, NH 58, Delhi Haridwar Bypass Road
Meerut UTTAR PRADESH 250005 India |
| Phone |
8901154505 |
| Fax |
|
| Email |
aakashdeep0089@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics and Dentofacial Orthopaedics, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, NH 58, Delhi Haridwar Bypass Road |
|
|
Primary Sponsor
|
| Name |
Dr. Aakashdeep |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, NH 58, Delhi Haridwar Bypass Road |
| 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 Aakashdeep |
Subharti Dental College |
Department of Orthodontics and Dentofacial Orthopaedics, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, NH 58, Delhi Haridwar Bypass Road Meerut UTTAR PRADESH |
8901154505
aakashdeep0089@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 have completed their braces treatment and now require retention of the achieved changes in their teeth after braces removal. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 Low Magnitude High Frequency Mechanical Vibrations
Group 2 Low Intensity Laser Therapy |
Evaluating the bone density and bone thickness in retention phase with fixed lingual bonded retainer after
giving Low Magnitude High Frequency Mechanical Vibrations (Group 1) and Low
Intensity Laser Therapy (Group 2) in orthodontically moved teeth. |
| Comparator Agent |
Only fixed lingual retainer without vibrations and lasers |
No additional intervention will be given and only fixed lingual
bonded retainer will be given. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1) Both extraction cases and non-extraction cases of mandibular arch.
2) Crowding or rotated teeth in mandibular arch.
3) Completion of fixed orthodontic treatment. |
|
| ExclusionCriteria |
| Details |
1) Non compliant patient.
2) Long term use of antibiotics, phenytoin, cyclosporine and anti inflammatory drugs, systemic corticosteroids and calcium channel
blockers.
3) Presence of periodontal diseases.
4) Patients with a history of parafunctional habits.
5) Systemic illness which affects bone metabolism.
6) Patients with a poor oral health.
7) Not willing for informed consent |
|
|
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 |
To evaluate the effect of low intensity high frequency mechanical vibrations and low intensity laser therapy on bone density and bone thickness during retention
phase with fixed bonded retainers in orthodontically treated teeth. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effect of low intensity high frequency mechanical vibrations and low intensity laser therapy on bone density and bone thickness during the retention phase with fixed
bonded retainers in orthodontically treated teeth. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
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)
|
10/07/2025 |
| 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="6" 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
|
In orthodontics, retention and stability should be considered an integral
part of the orthodontic treatment phase. The prime goal of an
orthodontist is to preserve what he/she has achieved at the end of the
treatment. Although the patient may feel that treatment is complete
when the appliances are removed, an important stage lies ahead: retention and stability. Retainer wear is difficult for many patients, and over time, compliance
declines. Consequently, there is a great need for methods to prevent
periodontal relapse and reduce retention time after receiving
orthodontic therapy. Over the past two decades, various biomedical agents, methods, and
techniques have been introduced to enhance orthodontic retention,
thus minimizing relapse. Two such methods are low intensity laser
therapy (LILT) and low magnitude, high-frequency vibrations (LMHF).
Recent studies suggest that low-magnitude, high-frequency (LMHF)
mechanical vibration can alter bone metabolism to stimulate cell
metabolism, osteoblastic gene expression, and bone formation. This
raises the possibility of using LMHF mechanical vibration as an
additional technique to hasten periodontal and bone healing after
orthodontic therapy. This could, in turn, encourage stability, reduce
retention times, and raise patient contentment. Both LLLT and HFV have gained attention in recent years for their
potential in improving various aspects of orthodontic treatment
outcomes. However, there is limited comparative research directly
assessing their effects on retention in human studies. By conducting a
head-to-head comparison, this study seeks to provide valuable insights
into the relative effectiveness of these modalities, thus aiding clinicians
in
making informed decisions regarding post-treatment retention
strategies |