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
|
|
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
|
|
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. |