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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  
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 
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  
Status 
Not Applicable 
 
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
 
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