CTRI Number |
CTRI/2021/01/030823 [Registered on: 29/01/2021] Trial Registered Prospectively |
Last Modified On: |
24/12/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Medical Device Dentistry |
Study Design |
Randomized, Crossover Trial |
Public Title of Study
|
Comparing two different Vibration frequencies on the rate of orthodontic Tooth Movement |
Scientific Title of Study
|
Comparative evaluation of the effect of two different Vibration frequencies on the rate of orthodontic Tooth Movement – A cross over randomized controlled trial. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Sakshi Sachdeva |
Designation |
Post Graduate Student |
Affiliation |
Manipal College of Dental Sciences, Mangalore Affiliated to Manipal Academy of Higher Education |
Address |
Manipal College of Dental Sciences, Mangalore
Light House Hill Road, Hampankatta Light House Hill Road, Hampankatta Dakshina Kannada KARNATAKA 575001 India |
Phone |
8197030435 |
Fax |
|
Email |
sakshisachdeva56@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Siddarth Shetty |
Designation |
Professor, Department of Orthodontics and Dentofacial Orthopaedics |
Affiliation |
Manipal College of Dental Sciences, Mangalore Affiliated to Manipal Academy of Higher Education |
Address |
Manipal College of Dental Sciences, Mangalore
Light House Hill Road, Hampankatta Manipal College of Dental Sciences, Mangalore
Light House Hill Road, Hampankatta Dakshina Kannada KARNATAKA 575001 India |
Phone |
9980044933 |
Fax |
|
Email |
siddarth.shetty@manipal.edu |
|
Details of Contact Person Public Query
|
Name |
Dr Sakshi Sachdeva |
Designation |
Post Graduate Student |
Affiliation |
Manipal College of Dental Sciences, Mangalore Affiliated to Manipal Academy of Higher Education |
Address |
Manipal College of Dental Sciences, Mangalore
Light House Hill Road, Hampankatta Manipal College of Dental Sciences, Mangalore
Light House Hill Road, Hampankatta Dakshina Kannada KARNATAKA 575001 India |
Phone |
8197030435 |
Fax |
|
Email |
sakshisachdeva56@gmail.com |
|
Source of Monetary or Material Support
|
Manipal College of Dental Sciences |
|
Primary Sponsor
|
Name |
Dr Sakshi Sachdeva |
Address |
Manipal College of Dental Sciences, Mangalore |
Type of Sponsor |
Other [Self Funded] |
|
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 |
Sakshi Sachdeva |
Manipal College of Dental Sciences, Mangalore |
Manipal College of Dental Sciences, Mangalore
Light House Hill Road, Hampankatta Dakshina Kannada KARNATAKA |
8197030435
sakshisachdeva56@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K006||Disturbances in tooth eruption, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
120 Hz Dental Vibrating Device |
A 120 Hz Dental Vibrating Device will be given to each of the patients and will be used by them for 5 mins every day for 2 months |
Intervention |
60 Hz Dental Vibrating Device |
A 60 Hz Dental Vibrating Device will be given to each of the patients and will be used by them for 10 mins every day for 2 months |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Both |
Details |
1. Subjects must be 18 - 45 years of age
2. Subjects that require bilateral 1st premolar extraction.
3. Subjects must have complete adult dentition (excluding third molars)
4. Subjects must have class I malocclusion or mild class II/III malocclusions |
|
ExclusionCriteria |
Details |
1. Subjects who are taking medication that could affect the level of inflammation, such as chronic antibiotics, phenytoin, cyclosporine, ant-inflammatory drugs, systemic corticosteroids, or calcium channel blockers.
2. Subjects missing adult teeth (except the 3rd molars) or with severe class II or class III malocclusion.
3. Subjects with skeletal class I but extreme dental malocclusion
4. Severe crowding that require extraction
5. Subjects having systemic diseases effecting bone metabolism
6. Subjects who are non-compliant regarding the recommended daily usage of the device |
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To compare the efficacy of 2 different frequency vibrations in accelerating tooth movement.
To measure the total amount of retraction in each of the frequencies by measuring distance from distal
of the canine to the third rugae. |
T0- Before the start of retraction
T1- After 2 months of using 1 frequency
1 Month washout period
T2- After 2 months of using second frequency |
|
Secondary Outcome
|
Outcome |
TimePoints |
To collect the GCF samples and compare the RANKL/OPG ratio for different frequencies in the
patients |
T0- Before the start of retraction
T1- After 2 months of using 1 frequency
1 Month washout period
T2- After 2 months of using second frequency |
|
Target Sample Size
|
Total Sample Size="28" Sample Size from India="28"
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
|
N/A |
Date of First Enrollment (India)
|
02/02/2021 |
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)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
As professionals, orthodontists aim to deliver a quality outcome for their patients. Not surprisingly, there is a demand by the public for shorter treatment times. Traditionally, orthodontic treatment involves 2 or more years in fixed appliances but with the advent of new technology and researches it has been reported to shorten to less than 2 years . This has been done to cater to the demands of the patients in these changing times for which various surgical and non-surgical treatment options have been opted for by the orthodontists. In order to enhance the orthodontic tooth movement, even mechanical vibrations have been used but, the paucity of clinical research evaluating their efficacy is of low quality . It has been widely known that treatment involving premolar extractions take a much longer time period as compared to the non-extraction cases . In such cases if it were possible to accelerate tooth movement to shorten the treatment time with a non-invasive procedure, this would result in a desirable outcome. Treatment time depends on the rate of tooth movement, which in turn depends on the rate of alveolar re- modeling . Therefore, it may be possible to increase the rate of tooth movement by accelerating the biologic response of PDL and alveolar bone . Although the exact mechanism of alveolar remodeling is not completely understood, there are 2 main hypotheses: (a) piezoelectricity generated within the alveolar bone, and (b) pressure-tension within the periodontal ligament. Periodontal ligament cells play a major role in initiation of the remodeling process during orthodontic tooth movement . Compression of PDL is a prerequisite for tooth movement. The balance between RANKL and OPG in PDL cells regulates bone remodeling during tooth movement . Compressive force up regulates RANKL via a PGE2-dependent mechanism in PDL cells . PGE2 is anti -inflammatory mediator produced by PDL cells in response to mechanical stress that acts in autocrine and paracrine manners to stimulate RANKL expression and promote bone resorption . In addition, the direct action of prostaglandins on an increasing of osteoclast function and bone resorption has been reported . Orthodontic tooth movement also causes root resorption . Studies have shown that these side effects are related mainly to the treatment time, so acceleration of orthodontic tooth movement thus shortening the treatment time. Vibration, being a completely non-invasive procedure has gained a lot of attention in is an effective solution the recent years although not well used. Currently, the optimal frequency and intensity of the vibration load are not well studied but it is believed that they are related to the tooth- periodontal ligament bone complex. The optimal frequency may be related to the natural frequency of the tooth –periodontal ligament bone complex . Through this study, the principal investigator would like to compare 2 different frequencies and determine that frequency which helps in accelerating the orthodontic treatment. Doing a molecular analysis and checking the RANKL/OPG ratios will confirm the same. |