FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
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 
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  
Status 
Not Applicable 
 
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.

 
Close