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CTRI Number  CTRI/2025/05/087861 [Registered on: 28/05/2025] Trial Registered Prospectively
Last Modified On: 13/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Other (Specify) [Clear Aligner Therapy]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Developing A Smart Computer Program Model using datasets and implementing it to Remotely Monitor and assess the Oral Hygiene of Patients Undergoing Clear Aligner Therapy  
Scientific Title of Study   Development of An Artificial Intelligence Based Algorithm for Oral Hygiene and Validation with Remote Monitoring during Clear Aligner Therapy  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  BINITA SAHA 
Designation  PG Student 
Affiliation  Manav Rachna Dental College, School of Dental Sciences, MRIIRS 
Address  Manav Rachna Dental College, School of Dental Sciences, MRIIRS, Department of Orthodontics and Dentofacial Orthopedics, SurajKund, Faridabad, Haryana, 121001

Faridabad
HARYANA
121001
India 
Phone  08695095851  
Fax    
Email  binitatfg@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Puneet Batra 
Designation  Dean, Professor and Head 
Affiliation  Manav Rachna Dental College, School of Dental Sciences, MRIIRS 
Address  Manav Rachna Dental College, School of Dental Sciences, MRIIRS, Department of Orthodontics and Dentofacial Orthopedics, SurajKund, Faridabad, Haryana, 121001

Faridabad
HARYANA
121001
India 
Phone  9810335961  
Fax    
Email  drpuneetbatra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashish Kumar Singh 
Designation  Professor 
Affiliation  Manav Rachna Dental College, School of Dental Sciences, MRIIRS 
Address  Manav Rachna Dental College, School of Dental Sciences, MRIIRS, Department of Orthodontics and Dentofacial Orthopedics, SurajKund, Faridabad, Haryana, 121001

Faridabad
HARYANA
121001
India 
Phone  08377878380  
Fax    
Email  drashish.singh@gmail.com  
 
Source of Monetary or Material Support  
Manav Rachna Dental College School Of Dental Sciences MRIIRS Depaertment no 3 GroundFloor Surajkund road Faridabad 
 
Primary Sponsor  
Name  Dr Binita Saha 
Address  Manav Rachna Dental College, School of Dental Sciences, MRIIRS, Department of Orthodontics and Dentofacial Orthopedics, SurajKund, Faridabad, Haryana, 121001 
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 
Dr Binita Saha  Manav Rachna Dental College School of Dental Sciences, MRIIRS   Department of Orthodontics, Room no 3, Ground Floor Surajkund road
Faridabad
HARYANA 		 8695095851

binitatfg@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Manav Rachna Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Other specified disorders of teeth and supporting structures 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clear Aligner Therapy  Patients undergoing clear aligner therapy who are monitored conventionally through in-office visits 
Intervention  Clear Aligner Therapy  Patients undergoing Clear Aligner therapy will be remotely monitored and their oral hygiene will be assessed using the Artificial Intelligence based algorithm 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Patients with more than 15 years of age.
Patients with permanent dentition.
Patients requiring clear aligner therapy.
Have daily access to a smartphone with a working camera and internet access.

 
 
ExclusionCriteria 
Details  Patients who are periodontally compromised.
Patients with any systemic disease and smokers.
Patients with poor compliance.
Specially abled individuals with a physical limitation that impaired their ability to take photographs.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Development of an
artificial
intelligence-
based algorithm.
Assessment of the oral
hygiene
status of
patients
monitored through the algorithm 		 Before the start of treatment (TO), 1 month after the start of treatment (T1), 2 months after the start of treatment (T2), 3 months after the start of treatment (T3) and 6 months after the start of treatment (T4). 
 
Secondary Outcome  
Outcome  TimePoints 
Comparative evaluation
of oral hygiene status
between
the
conventional
and
monitored patient group 		 T0— Before the start of treatment
T1-T4-After start of the treatment (1st, 2nd, 3rd, 6th month) 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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)   30/05/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [binitatfg@gmail.com].

  6. For how long will this data be available start date provided 18-06-2025 and end date provided 20-08-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   An artificial intelligence-based algorithm will be made to monitor the oral hygiene of  patients undergoing Clear Aligner Therapy remotely. It will be compared with a group of patients who will be monitored conventionally. 
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