FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/083482 [Registered on: 26/03/2025] Trial Registered Prospectively
Last Modified On: 25/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Space closure using different elastomeric modules during sliding mechanics 
Scientific Title of Study   Comparative evaluation of space closure using different elastomeric during sliding mechanics: An in vivo study  
Trial Acronym  not applicable  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Stuti Raj 
Designation  Assistant professor  
Affiliation  Sardar Patel Post Graduate Insititute of Dental and Medical Sciences 
Address  Department of Orthodontics, Room no 6,3rd floor, Sardar Patel Post Graduate Insititute of Dental and Medical Sciences, Raibareli Road, Utrathia, Vrindavan Colony, Lucknow

Lucknow
UTTAR PRADESH
226029
India 
Phone  08601331885  
Fax    
Email  dr.stuti.raj@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Stuti Raj 
Designation  Assistant professor  
Affiliation  Sardar Patel Post Graduate Insititute of Dental and Medical Sciences 
Address  Department of Orthodontics, Room no 6,3rd floor, Sardar Patel Post Graduate Insititute of Dental and Medical Sciences, Raibareli Road, Utrathia, Vrindavan Colony, Lucknow

Lucknow
UTTAR PRADESH
226029
India 
Phone  08601331885  
Fax    
Email  dr.stuti.raj@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Stuti Raj 
Designation  Assistant professor  
Affiliation  Sardar Patel Post Graduate Insititute of Dental and Medical Sciences 
Address  Department of Orthodontics, Room no 6,3rd floor, Sardar Patel Post Graduate Insititute of Dental and Medical Sciences, Raibareli Road, Utrathia, Vrindavan Colony, Lucknow

Lucknow
UTTAR PRADESH
226029
India 
Phone  08601331885  
Fax    
Email  dr.stuti.raj@gmail.com  
 
Source of Monetary or Material Support  
Self-Funded at Sardar Patel Postgraduate Institiute of Dental and Medical Sciences  
 
Primary Sponsor  
Name  Dr Stuti Raj 
Address  Department of Orthodontics, Room no 6,3rd floor, Sardar Patel Post Graduate Insititute of Dental and Medical Sciences, Raibareli Road, Utrathia, Vrindavan Colony, Lucknow-226029 
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 
Dr Stuti raj  Sardar Patel Post Graduate Insititute of Dental and Medical Sciences  Department of Orthodontics, Room no 6, 3rd floor, Sardar Patel Post Graduate Insititute of Dental and Medical Sciences, Raibareli Road, Utrathia, Vrindavan Colony, Lucknow 226029
Lucknow
UTTAR PRADESH 
08601331885

dr.stuti.raj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Sardar Patel Postgraduate Institiute of Dental and Medical Sciences   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  Space closure with elastomeric modules   Active tieback with Alastik(3M Unitek) Active tieback with O rings (Ormco) 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  •Patients of age between 19 to 25 years who are fit for orthodontic treatment.
•Healthy individuals with DMFT more than one will be considered.
•Patient with first premolar extraction in maxillary arch.
•Patients who are undergoing upper and fixed appliance treatment using pre-adjusted brackets system with a 022 slot with sliding mechanics.
•Patients in whom temporary anchorage devices can be used as anchorage.
•Retraction of each segment will be done on 19 into 25inch stainless steel arch wire.
 
 
ExclusionCriteria 
Details  •Patients with subsistence of periodontal disease.
•Patient with bone resorption.
•Patient having poor oral hygiene
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The outcome of the present study will benefit the patient as well as to the clinician. The result of the present study will enhance the orthodontic treatment plan in a better and precise manner  The space closure will be assessed at 6 weeks and 12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   07/04/2025 
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="1"
Months="8"
Days="20" 
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  

      In orthodontics, retraction of teeth is the prerequisite after the therapeutic extraction of the first permanent premolar to close the space or to relive the crowding. There are various methods of space closure which is categorized under friction and frictionless mechanics. The retraction of the tooth can be either segmental or enmasse. To prevent anchorage loss, TADs are most commonly used. The present study will include subjects who are undergoing fixed mechanotherapy and require maxillary first premolars extraction. In this study, single canine distalization is opted for the space closure. Canine will be distalized with the help of active tiebacks type one using Alastic (3M Unitek) and O-Rings (Ormco) elastomeric modules on right and left side respectively. The subjects will be divided into two groups. Right side of the maxillary arch will be grouped under Group A using Alastic (3M Unitek) elastomeric modules. Left side of the maxillary arch will be grouped under Group B using O-Rings (Ormco) elastomeric modules. The impression will be made periodically at 0, 6 and 12 weeks. Models will be prepared periodically. Space will be measured on models at three time intervals with the help of standardized Digital Vernier Caliper.  The distance will be measured from the tip of the canine and the mesiobuccal groove of the 2nd permanent molar of each maxillary right and left quadrant. There is limited data found in the literature till date for evaluating and comparing the space closure, using Alastic (3M Unitek) and O-Rings (Ormco) elastomeric modules in active tiebacks during distalization of canines. The present study will help the clinician to choose the best elastomeric modules for their patients.

 
Close