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
|
|
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 SUBHARTIÂ UNIVERSITY |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
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. |