| CTRI Number |
CTRI/2026/03/106428 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two wires engaged in fixed braces in upper and lower jaw to find which wire align with less duration of time |
|
Scientific Title of Study
|
A comparative invivo assessment of clinical efficiency between conventional cu-niti and newer cu-niti archwires during initial orthodontic alignment |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| VMSDC/IEC/Approval No.447 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poovizhi Thamizhkumaran |
| Designation |
postgraduate |
| Affiliation |
Vinayaka Missions Sankarachariyar Dental College |
| Address |
Vinayaka Missions Sankarachariyar Dental College Sankari Main Rd, Ariyanur, Salem, Tamil Nadu 636308
Salem
TAMIL NADU
636308
India |
| Phone |
8300298237 |
| Fax |
|
| Email |
poovizhirvka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hanumanth S |
| Designation |
Guide |
| Affiliation |
Vinayaka Missions Sankarachariyar Dental College |
| Address |
Vinayaka Missions Sankarachariyar Dental College Sankari Main Rd, Ariyanur, Salem, Tamil Nadu 636308
Salem
TAMIL NADU
636308
India |
| Phone |
9003425955 |
| Fax |
|
| Email |
hanumanth001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hanumanth S |
| Designation |
Guide |
| Affiliation |
Vinayaka Missions Sankarachariyar Dental College |
| Address |
Vinayaka Missions Sankarachariyar Dental College Sankari Main Rd, Ariyanur, Salem, Tamil Nadu 636308
Salem
TAMIL NADU
636308
India |
| Phone |
9003425955 |
| Fax |
|
| Email |
hanumanth001@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Poovizhi Thamizhkumaran |
| Address |
Vinayaka Missions Sankarachariyar Dental College Sankari Main Rd, Ariyanur, Salem, Tamil Nadu 636308 |
| 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 Poovizhi Thamizhkumaran |
Vinayaka missions Sankarachariyar dental college |
Room No 9 3rd floor department of orthodontics Vinayaka Missions Sankarachariyar Dental College Sankari Main Rd, Ariyanur, Salem, Tamil Nadu 636308
Salem
TAMIL NADU |
08300298237
poovizhirvka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Of VMSDC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Those seeking orthodontic treatment at VMSDC |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Copper NiTi archwire |
In Comparator group 0.016 Conventional Copper NiTi archwire will be engaged in bracket slots for 16 weeks |
| Intervention |
SmartArchTM Multiforce archwire |
In Intervention group 0.016 SmartArchTM Multiforce archwire will be engaged in bracket slots for 16 weeks |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Patient with Class I malocclusion with mild to moderate crowding
Aged between 15 to 25 years with permanent dentition
Little s irregularity index of minimum 4mm and maximum of 8 mm
No history of trauma or root resorption in incisors
Patient who are willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Previous orthodontic treatment
less than 4mm crowding with Little s irregularity index
patients with periodontally compromised teeth and endodontically treated
Patient with spacing in anterior region
patients with a blocked out tooth that did not allow for placement of the bracket at the initial bonding appointment
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate the alignment efficiency between Conventional CuNiTi arch wires (Ormco) and SmartArchTM Multiforce archwires (Ormco) |
Baseline and at every month for the period of 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the changes at intercanine and intermolar width in maxillary/ mandibular arch in both groups.
To measure the incisor inclination changes between Conventional CuNiTi arch wires (Ormco) and SmartArchTM Multiforce archwires (Ormco) after complete initial alignment ( Little’s irregularity index of score 0)
|
Baseline and at every month for the period of 4 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/03/2026 |
| 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="0"
Months="4"
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
|
This is a single blinded randomized controlled trial to compare and evaluate alignment efficiency between Conventional Copper NiTi arch wire and SmartArchTM Multiforce archwire. It is conducted at VMSDC Salem The primary outcome is to compare and evaluate the alignment efficiency between Conventional CuNiTi arch wires (Ormco) and SmartArchTM Multiforce archwires (Ormco) Secondary outcome is to evaluate change in intercanine and intermolar width in maxillary/mandibular arches in both groups and to measure the incisor inclination changes between Conventional CuNiTi arch wires (Ormco) and SmartArchTM Multiforce archwires (Ormco) after complete initial alignment (Little s irregularity index of score 0) primary and secondary outcome will be evaluated by taking intraoral scans at every interval and calculated values through computer software and incisor inclination changes will be evaluated by taking lateral cephalograms at baseline and at 4th month.
|