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
|
|
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
|
|
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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