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CTRI Number  CTRI/2024/05/066706 [Registered on: 03/05/2024] Trial Registered Prospectively
Last Modified On: 03/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   to check the changes in the mechanical properties after aligner wear for 7 and 14 days  
Scientific Title of Study   Comparative Evaluation of Mechanical Properties of 3 Different Aligner Materials: An in-vivo Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Muskan 
Designation  Post Graduate Student  
Affiliation  Sudha Rustagi College of Dental Sciences and Research Institute  
Address  Department of orthodontics Room number 4 Sudha Rustagi College of Dental Sciences and Research Institute, Faridabad
H.no 70, Sector 13 Hisar Haryana
Hisar
HARYANA
121002
India 
Phone  9467000076  
Fax    
Email  muskan7013@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Sridhar Kannan  
Designation  Professor  
Affiliation  Sudha Rustagi College of Dental Sciences and Research Institute  
Address  Sudha Rustagi College of Dental Sciences and Research Institute, Faridabad
Sudha Rustagi College of Dental Sciences and Research Institute, Faridabad
Faridabad
HARYANA
121002
India 
Phone  9818212912  
Fax    
Email  sridharnoopur@gmail.com  
 
Details of Contact Person
Public Query  
Name  Muskan 
Designation  Post Graduate Student  
Affiliation  Sudha Rustagi College of Dental Sciences and Research Institute  
Address  Department of orthodontics Room number 4 Sudha Rustagi College of Dental Sciences and Research Institute, Faridabad

Faridabad
HARYANA
121002
India 
Phone  9467000076  
Fax    
Email  muskan7013@gmail.com  
 
Source of Monetary or Material Support  
Department of orthodontics Sudha Rustagi College of Dental Sciences and Research Institute, Faridabad  
 
Primary Sponsor  
Name  Muskan Agarwal 
Address  sudha rustagi college of dental sciences and research, faridabad 
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 
Muskan Agarwal  sudha rustagi college of dental sciences and research, faridabad  Department of orthodontics room number 4 sector 89 121002
Faridabad
HARYANA 		 09467000076

muskan7013@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRCDSR Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Mild to moderate crowding patients  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aligner  changes in mechanical properties of 3 different aligner materials at 0 day,7 day ,14 day 
Comparator Agent  aligner  mechanical properties of aligner material PET,PETG,PTU 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1.Patient with goof oral hygiene
2.Patient with mild to moderate malocclusion
3.Patient with good compliance to wear aligners 4.atleast 20-22 hours per day 
 
ExclusionCriteria 
Details  1.Patient with poor oral hygiene.
2.Patient with a habit of smoking, tobacco chewing or bruxism.
3.Any other food habit which could alter the aligner material properties.
4.Distorted aligners.
5.Patient with Esophageal reflux as it may affect the property of the material.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Mechanical Propeties of aligner  4 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 1 
Date of First Enrollment (India)   10/07/2024 
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="0"
Days="21" 
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  

This is a prospective, randomised double blind study of three aligner materials PET, PETG and TPU on 5 patients of each material which includes students and patients visiting in the department of orthodontics from Sudha Rustagi College of Dental Sciences willing for orthodontic treatment. Samples of each material will be taken and thermoformed using thermoforming machine. Two sets of aligners need to be fabricated at the start of the study. One set is sent for study and one is delivered to the patient. Mechanical properties of each aligner, in terms of tensile strength, flexural strength, surface hardness will be obtained, using universal testing machine, and Vickers hardness tester before delivering the aligners to the patient.
For each material we will carry out tests at interval of 7 days and 14 days after wear.
At 7th day of aligner wear, the aligners will be collected from the patient, washed with distilled water and immediately sent for the tests. An additional aligner of the same series or another set of series will be delivered to the patient to replace the aligner collected for test purposes. Similar methodology will be used for 14th day.

 
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