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CTRI Number  CTRI/2023/11/059521 [Registered on: 03/11/2023] Trial Registered Prospectively
Last Modified On: 13/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To check the distance the teeth moves when two different brackets are used 
Scientific Title of Study   Comparative evaluation of distal movement and external apical root resorption of maxillary canines bonded with a combination of zinc oxide-tin oxide nanoparticle coated and non-coated ceramic brackets- a split-mouth randomized clinical trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arshya A Kumar 
Designation  Post graduate 
Affiliation  Saveetha Dental College and Hospital 
Address  Clinic 27, Department of Orthodontics,Saveetha Dental College and Hospital, Poonamalle High Road
Saveetha Dental College and Hospital, Poonamalle High Road
Chennai
TAMIL NADU
600077
India 
Phone  9921347515  
Fax    
Email  152108006.sdc@saveetha.com  
 
Details of Contact Person
Scientific Query  
Name  Ravindra Kumar Jain 
Designation  Professor and Head 
Affiliation  Saveetha Dental College and Hospital 
Address  Clinic 27, Department of Orthodontics,Saveetha Dental College and Hospital, Poonamalle High Road

Chennai
TAMIL NADU
600077
India 
Phone  9884729660  
Fax    
Email  ravindrakumar@saveetha.com  
 
Details of Contact Person
Public Query  
Name  Arshya A Kumar 
Designation  Post graduate 
Affiliation  Saveetha Dental College and Hospital 
Address  Clinic 27, Department of Orthodontics,Saveetha Dental College and Hospital, Poonamalle High Road

Chennai
TAMIL NADU
600077
India 
Phone  9921347515  
Fax    
Email  152108006.sdc@saveetha.com  
 
Source of Monetary or Material Support  
Dental Matrix, Authorised distributor of Ormco, No. 601, HMT Layout, RT Nagar, Bengaluru 560032 
 
Primary Sponsor  
Name  Arshya A Kumar 
Address  Clinic 27, Department of Orthodontics, Saveetha Dental College and Hospital, Poonamalle High Road 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Saveetha Dental College and Hospital  Saveetha Dental College and Hospital, Poonamalle High Road 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arshya A Kumar  Department of Orthodontics and Dentofacial Orthopaedics  Clinic 27, 5th floor, Department of Orthodontics and Dentofacial Orthopaedics, Saveetha Dental College and Hospital, Poonamalle High Road, Chennai
Chennai
TAMIL NADU 		 9921347515

152108006.sdc@saveetha.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Dental College & Hospital Institutional Ethics Committee SDC IHEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  subjects requiring individual canine retraction during fixed orthodontic treatment 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Non-coated Ceramic brackets  Subjects requiring individual canine retraction during fixed orthodontic treatment 
Intervention  Zinc oxide- tin oxide nanocoated ceramic brackets  Subjects requiring individual canine retraction during fixed orthodontic treatment 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Subjects requiring individual canine retraction during fixed orthodontic treatment, Patients with a full complement of healthy non- carious permanent teeth, canines and first premolars nearly in good alignment, a treatment plan for extraction of maxillary first premolars.
 
 
ExclusionCriteria 
Details  Debonding of brackets from canines or anchorage teeth, removal of retracting coil springs during treatment, irregular follow‐up visits of patients and patients with asymmetrical arches were excluded from the study. Subjects with congenital enamel defects or hypoplasia of partially erupted teeth, physically or mentally handicapped, and craniofacial syndromes  
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Rate of canine retraction
 		 4 weeks, 8 weeks and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
canine rotation, tipping of canine  3 months 
 
Target Sample Size   Total Sample Size="13"
Sample Size from India="13" 
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)   15/11/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/11/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="15" 
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 - All of the individual participant data collected during the trial, after de-identification.

  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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [152108006.sdc@saveetha.com].

  6. For how long will this data be available start date provided 01-09-2024 and end date provided 01-12-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  
Comparative evaluation of distal movement and external apical root resorption of maxillary canines bonded with a combination of zinc oxide-tin oxide nanoparticle coated and non-coated ceramic
brackets- a split-mouth randomised clinical trial.

Aim: To evaluate the distal movement and external apical root resorption of maxillary canines bonded with a combination of zinc oxide-tin oxide nanoparticle-coated and non-coated ceramic brackets.

Sample size:!3 patients 
Split mouth study 
Group 1- 13 quadrants- zinc oxide-tin oxide nanoparticle coated brackets
Group 2- 13 quadrants- non-coated ceramic brackets

Methodology: The horizontal distance is to be calculated between the pre-retraction and post-retraction values.
The rate of canine retraction is to be calculated by dividing the amount of canine retraction by the time taken for the retraction.
External apical root resorption is evaluated with pre and post-CBCTs.




 
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