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CTRI Number  CTRI/2026/01/102179 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 23/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Evaluation of the alignment efficiency of three different archwires in the initial phase of orthodontic treatment for 16 weeks. 
Scientific Title of Study   Evaluation of the alignment efficiency of conventional, superelastic and heat activated copper nickel titanium archwires in the initial phase of fixed orthodontic treatment over a 16 week period A single center double blind randomised controlled clinical study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manas Grover  
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  9781469444  
Fax    
Email  manasgrover28@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

Solan
HIMACHAL PRADESH
173205
India 
Phone  9896050995  
Fax    
Email  sanjaymtdr@yahoo.com  
 
Source of Monetary or Material Support  
Bhojia Dental college and hospital, Bhud, Baddi, Solan , Himachal pradesh 173205 India  
 
Primary Sponsor  
Name  Bhojia Dental college and hospital, Baddi 
Address  Bhojia Dental college 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 Manas Grover  Bhojia Dental College and hospital Baddi Himachal Pradesh  Department of orthodontics and dentofacial orthopedics , room no 4 , bhojia dental college and hospital ,bhud, baddi , solan , Himachal pradesh.
Solan
HIMACHAL PRADESH 		 9781469444

manasgrover28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE BHOJIA DENTAL COLLEGE AND 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 
Comparator Agent  Conventional nickel titanium arch wire   Two sequential sizes of conventional niti archwire will be used to relieve crowding over a period of 16 weeks  
Intervention  Heat activated Copper nickel titanium archwire  Two sequential sizes of heat activated copper niti archwire will be used to relieve crowding over a period of 16 weeks 
Intervention  Superelastic nickel titanium arch wire  Two sequential sizes of superelastic niti archwire will be used to relieve crowding over a period of 16 weeks  
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Patients with good periodontal and gingival health, no systemic disease or relevant medical history, requiring fixed orthodontic treatment with moderate to severe mandibular anterior crowding, all mandibular teeth present up to first molars, and no previous history of orthodontic treatment. 
 
ExclusionCriteria 
Details  Patients with blocked-out mandibular anterior teeth preventing bracket placement, lower incisor extraction planned, missing/impacted lower incisors or canines, poor oral hygiene or periodontal compromise, craniofacial anomalies, TMJ pathology, systemic disease, nickel sensitivity, oral habits, posterior crossbite, untreated caries, mucosal ulcers, or unwillingness to participate.  
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in mandibular anterior irregularity measured using Little’s Irregularity Index (LII) on dental casts. . The difference between T0 and T4 will provide the reduction in mandibular anterior irregularity which will give an assessment of tooth movement happening from the effect of the three aligning wires over the entire study period (T0-T4).   Time points is specific time at which the outcome will be assessed/estimated i.e. at baseline (T0), 4 weeks(T1) & 8 weeks(T2), 12 weeks (T3) and 16 weeks (T4) 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of mandibular anterior irregularity correction at monthly intervals  4th week (T1), 8th week (T2), 12th week (T3) and 16th week (T4) 
Subjects achieving complete alignment  T4 
Arch Dimensions   T0 and T4 
Cephalometric Measurements for Lower Incisor Inclinations   T0 and T4 
Root Resorption   T0 and T4 
Pain Perception   T0,T1,T2,T3,T4 at 4hr 24 hrs 3 days and 1 week 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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)   10/02/2026 
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)   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 - 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 [manasgrover28@gmail.com].

  6. For how long will this data be available start date provided 10-02-2026 and end date provided 10-02-2028?
    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 clinical study is a single-center, double-blind, randomized controlled clinical trial designed to compare the alignment efficiency of conventional NiTi, superelastic NiTi, and heat-activated copper NiTi archwires during the initial phase of fixed orthodontic treatment. Seventy-eight patients with moderate to severe mandibular anterior crowding will be randomly allocated into three equal groups and followed for 16 weeks. Alignment will be evaluated primarily using Little’s Irregularity Index at monthly intervals, with secondary outcomes including arch dimensional changes,lower incisor inclinations, pain perception, and root resorption.

 
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