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CTRI Number  CTRI/2026/01/101251 [Registered on: 15/01/2026] Trial Registered Prospectively
Last Modified On: 18/08/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Efficiency of Burstone T-Loop Versus Modified Marcotte Spring for Maxillary Canine Retraction in Orthodontic Patients 
Scientific Title of Study   Comparative evaluation of the efficiency of segmental maxillary canine retraction using Burstone T-loop versus Modified Marcotte retraction spring - A prospective, single-blind, split mouth, randomized controlled clinical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kanchan  
Designation  Postgraduate student 
Affiliation  Bhojia Dental College and Hospital 
Address  Department of Orthodontics and Dentofacial Orthopedics, Room No 4, Bhojia Dental College and Hospital Baddi, Solan

Solan
HIMACHAL PRADESH
173205
India 
Phone  8628920142  
Fax    
Email  kanchanshaishav@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Mittal 
Designation  Professor and Head 
Affiliation  Bhojia Dental College and Hospital 
Address  Department of Orthodontics and Dentofacial Orthopedics, Room No 4, Bhojia Dental College and Hospital Baddi, Solan

Solan
HIMACHAL PRADESH
173205
India 
Phone  9896050995  
Fax    
Email  sanjaymtdr@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjay Mittal 
Designation  Professor and Head 
Affiliation  Bhojia Dental College and Hospital 
Address  Department of Orthodontics and Dentofacial Orthopedics, Room No 4, Bhojia Dental College and Hospital Baddi, Solan


HIMACHAL PRADESH
173205
India 
Phone  9896050995  
Fax    
Email  sanjaymtdr@yahoo.com  
 
Source of Monetary or Material Support  
Bhojia Dental College and Hospital,Baddi 
 
Primary Sponsor  
Name  Bhojia dental collage and hospital Baddi 
Address  Bhojia dental collage and hospital Bhud Baddi Solan 173205  
Type of Sponsor  Private hospital/clinic 
 
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 Kanchan  Bhojia Dental College and Hospital Budh Baddi HP  Department of Orthodontics and Dentofacial Orthopedics, Room No 4, Bhojia Dental College and Hospital Baddi, Solan
Solan
HIMACHAL PRADESH 		 8628920142

kanchanshaishav@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTEETHICSCOMMITTEEBHOJIADENTAL COLLEGEAND HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  burstone T- loop  burstone T-loop will be used in the maxillary arch on one side of the arch for retracting canines, after initial alignment and leveling, for 18 weeks with a follow up after every 6 weeks 
Comparator Agent  modified marcotte retraction spring  modified marcotte retraction spring will be used in the maxillary arch on other side of the arch for retracting canines, after initial alignment and leveling, for 18 weeks with a follow up after every 6 weeks 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  full development of teeth except 3rd molars, class I or class II molar relations, patients requiring extraction of maxillary 1st premolars, good gingival and periodontal health, patient consent, no systemic disease. 
 
ExclusionCriteria 
Details  class III malocclusion, poor oral hygiene, carious or restored 1st molars, crossbite, developmental disorders, patients on any medications. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
maxillary canines retraction  Baseline, 6 weeks, 12 weeks, 18 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
canine rotation, molar anchorage loss  T0,T1,T2,T3 
canine inclinations  T0, T3 
canine external apical root resorption  T0, T3 
subjective pain assessment  T0,T1,T2,T3 at 24 hours, 48 hours, 96 hours and 7th day 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   30/01/2026 
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)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  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 - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 15-01-2026 and end date provided 15-01-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   this prospective clinical study will evaluate the efficacy of burstone T- loop and modified marcotte retraction spring in retracting the maxillary canines in fixed orthodontic patients. a split- mouth design will be followed where one side of the maxillary arch will incorporate burstone T- loop and the other side will incorporate modified marcotte spring. the study will be carried out for 18 weeks with a follow-up after every  6 weeks. retraction of canines along with its rotation, change in inclination, its root resorption and pain associated with these loops will be observed.  
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