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CTRI Number  CTRI/2025/06/088729 [Registered on: 12/06/2025] Trial Registered Prospectively
Last Modified On: 05/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the effects of two different sets of wires for correcting lower teeth irregularity in individuals undergoing fixed braces treatment. 
Scientific Title of Study   Comparative evaluation of the alignment and levelling efficiency of new rectangular and conventional archwire sequences in the mandibular arch in mild to moderate crowding cases. An open-label assessor-blinded Randomized Controlled 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  Monisha J 
Designation  Senior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry 
Address  Division of Orthodontics and Dentofacial Orthopedics, Department of Dentistry, I Floor- Screening OPD, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri Nagar, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9790923793  
Fax    
Email  monishasukumar18@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Balasubramanian Madhan 
Designation  Professor (Senior Scale) 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry 
Address  Division of Orthodontics and Dentofacial Orthopedics, Department of Dentistry, I Floor- Screening OPD, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri Nagar, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9498066130  
Fax    
Email  JD1128@jipmer.ac.in  
 
Details of Contact Person
Public Query
 
Name  Balasubramanian Madhan 
Designation  Professor (Senior Scale) 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry 
Address  Division of Orthodontics and Dentofacial Orthopedics, Department of Dentistry, I Floor- Screening OPD, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri Nagar, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9498066130  
Fax    
Email  JD1128@jipmer.ac.in  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri Nagar, Puducherry-605006, India 
 
Primary Sponsor  
Name  Monisha J 
Address  Division of Orthodontics and Dentofacial Orthopedics, Department of Dentistry, I Floor- Screening OPD, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri Nagar, Puducherry 
Type of Sponsor  Other [Investigator-funded] 
 
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 Balasubramanian Madhan  Jawaharlal Institute of Postgraduate Medical Education and Research  Division of Orthodontics and Dentofacial Orthopedics, Department of Dentistry, I Floor- Screening OPD
Pondicherry
PONDICHERRY 
9498066130

JD1128@jipmer.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- Interventional Studies, JIPMER, Puducherry  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 Archwire sequence (CAS) of 0.014-inch NiTi, 0.016-inch NiTi, 0.016 x 0.022-inch NiTi, 0.016 x 0.022-inch SS, 0.017 x 0.025-inch SS  All the patients will be bonded with 0.18 Slot MBT prescription brackets and tubes using the standard bonding protocol. The following archwire sequence will be used in the lower arch: 0.014-inch Nickel Titanium (NiTi), 0.016-inch NiTi, 0.016 x 0.022-inch NiTi, 0.016 x 0.022-inch Stainless Steel (SS), and 0.017 x 0.025-inch SS. The overall treatment duration with this archwire sequence is expected to be 6–8 months. 
Intervention  Three Rectangular Archwire Sequence (TRAS) of 0.017 x 0.025-inch braided NiTi, 0.017 x 0.025-inch NiTi, 0.017 x 0.025-inch SS  All the patients will be bonded with 0.18 Slot MBT prescription brackets and tubes using the standard bonding protocol. The following archwire sequence will be used in the lower arch: 0.017 x 0.025-inch braided NiTi, 0.017 x 0.025-inch NiTi, 0.017 x 0.025-inch SS. The overall treatment duration with this archwire sequence is expected to be 5–7 months. 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. Littles irregularity index of 3-6 mm in lower anteriors, with no more than 2 mm for any contact
2. Curve of Spee (CoS) of 3-5 mm 
 
ExclusionCriteria 
Details  1. Known Nickel allergy
2. Systemic diseases or medications influencing tooth movement, root resorption, or bone metabolism
3. Attached gingiva in any anterior tooth less than 1.5 mm
4. Clinical attachment loss of greater than 1 mm in any tooth
5. History of previous orthodontic treatment
6. History of trauma to lower incisors/ root canal treated lower incisors
7. Pre-existing evident root resorption of lower incisors 
 
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 
Alignment and Levelling efficiency: These will be assessed using orthodontic models and calculated as the reduction in Littles irregularity index (in mm) per month and the reduction in Curve of Spee (in mm) per month, respectively.  T0 - At Baseline
T1 - End of alignment and levelling (5-8 months) 
 
Secondary Outcome  
Outcome  TimePoints 
Lower incisor position change: This will be assessed with lateral cephalograms using the following variables
Linear (in mm)
i. L1i - NB
ii. L1i – Sym-P (Perpendicular to Go-Me drawn through the distal most point on the posterior outline of the symphysis)
iii. L1a - Sym-P
iv. L1 incisal tip movement / L1 apex movement
v. L1 Root point (point on the long axis, 2/3rd from the incisal edge) - Go-Me

Angular (in degrees)
vi. L1 to NB
vii. IMPA 
T0 - At Baseline
T1 - End of alignment and levelling  
Total number of bond failures, assessed from history and clinical examination  Bond failures will be evaluated during the entire study period. 
Root resorption in lower incisors evaluated with intra-oral periapical radiographs   T0 - At Baseline
T1 - End of alignment and levelling  
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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)   15/07/2025 
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="3"
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 - NO
Brief Summary  

Lower incisor proclination is a frequently observed adverse effect during the alignment and levelling stages of fixed orthodontic treatment. This is partly attributed to the inadequate torque control provided by the initial round wires with the Conventional Archwire Sequence (CAS). While rectangular archwires offer improved torque control, the higher forces they generate often limit their application at this stage.

Recently, braided rectangular Nickel Titanium archwires have emerged as a promising alternative, offering low force levels and enabling their application as the initial archwire. Hence, it is now possible to both initiate the treatment and complete the alignment and leveling stage with rectangular archwires. 

In this context, we propose the Three Rectangular Archwires Sequence (TRAS) of 0.017 x 0.025-inch braided NiTi, 0.017 x 0.025-inch NiTi, 0.017 x 0.025-inch SS for use in 0.018 slot appliances. The study aims to evaluate the alignment and levelling efficiency of this TRAS and compare it with the CAS (0.014-inch NiTi, 0.016-inch NiTi, 0.016 x 0.022-inch NiTi, 0.016 x 0.022-inch SS, 0.017 x 0.025-inch SS) in the mandibular arch.

Patients to be started on fixed appliance therapy at the Orthodontic Clinic, JIPMER, Puducherry, will be screened for eligibility. Thirty-eight individuals who meet the selection criteria and willing to participate will be included in the study. They will be bonded with 0.018-inch slot MBT prescription brackets and tubes using the standard bonding protocol. Based on a computer-generated random sequence, the participants will be allocated to receive either of the two archwire sequences. 

The primary outcomes are alignment and levelling efficiency (estimated as change in the Little’s Irregularity Index and Curve of Spee measured from study models made at baseline and at the end of alignment and levelling). The secondary outcomes include lower incisor position change (estimated using linear and angular variables from lateral cephalograms made at baseline and at the end of alignment and levelling), the number of bond failures during the assessment period (recorded from history and clinical examination), and root resorption assessed from intra-oral periapical radiographs at baseline and at the end of alignment and levelling.

Per Protocol analysis will be followed for group comparisons. Paired T-test /Wilcoxon signed rank test will be used for the intra-group comparisons of alignment and levelling efficiency, incisor inclination changes, and root resorption. The inter-group differences in the same will be analysed with the Independent Samples T-test/ Mann-Whitney test. The difference in the proportion of bond failures between the groups will be compared with Chi-square/ Fisher’s exact test. All the tests will be two- tailed with p<.05.


 
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