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CTRI Number  CTRI/2025/07/090569 [Registered on: 09/07/2025] Trial Registered Prospectively
Last Modified On: 08/07/2025
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 MECHANICAL PROPERTIES OF THERMOFORMED AND DIRECTLY PRINTED ALIGNER MATERIALS 
Scientific Title of Study   COMPARATIVE EVALUATION OF MECHANICAL PROPERTIES OF THERMOFORMED AND DIRECTLY PRINTED 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  Divya Lohia 
Designation  PG student, orthodontics  
Affiliation  Sudha Rustagi College of Dental Sciences and Research 
Address  Dept of Orthodontics and Dentofacial Orthopaedics Sudha Rustagi College of Dental Sciences and Research sec 89 Faridabad

Faridabad
HARYANA
121002
India 
Phone  9958894688  
Fax    
Email  divyalohia1806@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gurkeerat Singh 
Designation  Head Professor, orthodontics 
Affiliation  Sudha Rustagi College of Dental Sciences and Research 
Address  Dept of Orthodontics and Dentofacial Orthopaedics Sudha Rustagi College of Dental Sciences and Research sec 89 Faridabad

Faridabad
HARYANA
121002
India 
Phone  9811063930  
Fax    
Email  drgurkeeratsingh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gurkeerat Singh 
Designation  Head Professor, orthodontics 
Affiliation  Sudha Rustagi College of Dental Sciences and Research 
Address  Dept of Orthodontics and Dentofacial Orthopaedics Sudha Rustagi College of Dental Sciences and Research sec 89 Faridabad

Faridabad
HARYANA
121002
India 
Phone  9811063930  
Fax    
Email  drgurkeeratsingh@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Divya Lohia 
Address  Sudha Rustagi College of Dental Sciences and Research Institute 
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 
Divya Lohia  Sudha Rustagi College of Dental Sciences and Research  Department of Orthodontics, room number 4, sector 89 121002 Faridabad HARYANA
Faridabad
HARYANA 		 09958894688

divyalohia1806@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 dental crowding  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  aligner  changes in mechanical properties of two different aligner materials at 0 day, 7 day and 14 day 
Comparator Agent  aligner  mechanical properties of aligner material PETG and 3D printed aligner material 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1.Patient with good oral hygiene
2.Patient with mild to moderate malocclusion.
3.Patient with good compliance to wear aligners
4.Patient should wear 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.
•Patient with Esophageal reflux as it may affect the property of the material.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
mechanical properties of aligners  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
to determine which material is best for aligner fabrication  8 weeks 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
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)   28/07/2025 
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="2"
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  

This in vivo study aims to evaluate and compare the mechanical properties of two orthodontic aligner materials thermoformed and directly printed. With increasing demand for aesthetic orthodontic options clear aligners have become widely used. However conventional thermoformed aligners often show limitations such as low strength and dimensional instability. Directly printed aligners using advanced biocompatible materials like TC85DAC offer a potential improvement in these properties. The study involves sixteen patients divided into two groups each receiving one type of aligner. Mechanical properties such as tensile strength flexural strength and surface hardness are assessed at the beginning of treatment and after 14 days of intraoral use. Data is analyzed statistically to determine significant differences. The study has received ethical clearance and informed consent is obtained from all participants. Results are awaited and the findings are expected to guide material selection for improved clinical outcomes in aligner therapy.


 
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