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CTRI Number  CTRI/2023/07/055412 [Registered on: 20/07/2023] Trial Registered Prospectively
Last Modified On: 18/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative evaluation of the speed orthodontic tooth movement by giving high frequency and low frequency vibrations. 
Scientific Title of Study   Comparative assessment of rate of orthodontic tooth movement with high frequency vibrations and low frequency vibrations: 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 Akhil Anton Joy 
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  9497282341  
Fax    
Email  akhilantonjoy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pradeep Raghav 
Designation  Professor and Head,Department of Orthodontics and Dentofacial Orthopaedics 
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  9837175914  
Fax    
Email  drpradeepraghav@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Akhil Anton Joy 
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  9497282341  
Fax    
Email  akhilantonjoy@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 Akhil Anton Joy 
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 Akhil Anton Joy  Subharti Dental College and Hospital  Department of Orthodontics and Dentofacial Orthopaedics,Room No. 7, 2nd floor, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, NH-58, Delhi-Haridwar Bypass Road
Meerut
UTTAR PRADESH 
9497282341

akhilantonjoy@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 requiring therapeutic extraction space closure during fixed orthodontic treatment.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individual canine retraction with the application of High frequency (Group-1) and Low frequency (group -2) vibrations on one side on maxillary arch.   Vibrations of High frequency and low frequency are given to Group-1 and group-2 samples respectively during the stage of individual canine retraction using Nickel titanium coil spring during the fixed orthodontic therapy to evaluate the effect of vibrations to accelerate the rate of orthodontic tooth movement. The study has a follow-up period of six months or until the complete closure of space in the interval of 30 days. This has been done as a split-mouth trial where one side of the maxillary arch is the intervention site and the other side is the comparator side. 
Comparator Agent  Individual Canine Retraction without Vibrations.  Individual canine retraction without vibrations using Nickel titanium coil spring during the fixed orthodontic therapy is done on the contralateral side of the maxillary arch. The study has a follow-up period of six months or until the complete closure of space in the interval of 30 days.  
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. Angle’s Class I bimaxillary and Angle’s Class II div 1 malocclusion requiring 1st premolar extraction.
2. No systemic disease.
3. No radiographic evidence of bone loss.
4. No history of periodontal therapy.
5. No current active periodontal disease, Probing depth < 4 mm in all teeth.
 
 
ExclusionCriteria 
Details  1. Non–compliant patient, inability to maintain proper oral hygiene.
2. History of prior orthodontic treatment.
3. Long term use of antibiotics, phenytoin, cyclosporine and anti – inflammatory,
Systemic corticosteroids & calcium channel blockers.
4. Systemic illness which affects bone metabolism.
5. Extreme skeletal Class II malocclusion, Overjet > 10mm.
6. 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 
Effect of high frequency vibrations & low frequency vibrations in rate of orthodontic tooth movement.

Comparison of the rate of orthodontic tooth movement in high frequency & low frequency vibrations.

 
6 months

 
 
Secondary Outcome  
Outcome  TimePoints 
Effects of mechanical vibrations on root resorption.  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)   28/07/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/07/2023 
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  

 

The duration of orthodontic treatment is an important factor for both orthodontists and their patients. Reducing treatment time is one of the today’s most challenging issue in orthodontics, because increased treatment duration has been associated with an increased risk of caries, periodontal problems, prolonged pain as well as a higher risk of root resorption. To combat this, many initiatives have been made in recent years to accelerate orthodontic tooth movement using invasive (surgical) and non-invasive (pharmacological and physical stimulation) approaches along with conventional orthodontic force.

Vibration has been a relatively new field of interest to researchers which increases the rate of orthodontic tooth movement by accelerating the periodontal and bony tissue modelling and remodelling processes with the advantage of minimal side effects in comparison to other methods. Initial studies to evaluate the effect of vibration on orthodontic tooth movement, which were conducted on animals, have shown promising results. Evidence from such animal studies had suggested that cells respond more rapidly to oscillation force as compared to a constant force when they have been subjected to multiple cyclic (vibration) forces. Osteoblasts, osteoclasts, and periodontal ligament fibroblasts are intimately involved in facilitating tooth movement as these cell types are sensitive to perceiving and responding to mechanical signals, and therefore, are targeted by devices that aim at accelerating the movement of teeth.

Various commercial vibratory devices have been designed to provide a cyclic vibrational force of both low and high frequency, which can be directly used by patients. Tooth Masseuse (111 Hz), AcceleDent (30 Hz), and Vpro5 appliances (120 Hz) have been commonly used. Few studies using vibratory devices in orthodontic tooth movement, low frequency devices (30 Hz; 20gf) do not promote tooth movement significantly whereas high frequency devices (120 Hz,111Hz; 6gf,5.2gf) shortens treatment time by enhancing tooth movement. Also, in studies comparing cellular responses in high frequency and low frequency device both caused increased cell proliferation and gene expression in osteoblasts and fibroblasts, but the response to high frequency one was slightly greater than low frequency.Still it’s a topic of controversy that the rate of orthodontic tooth movement is increased more by high frequency vibrations or the low frequency vibrations.

Hence, this current study is done to compare the rate of tooth movement with high frequency and low frequency mechanical vibrations using customized vibratory device and to evaluate root resorption in subjects with fixed conventional orthodontic therapy.

 
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