| CTRI Number |
CTRI/2025/10/096257 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
18/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of root resorption in lower anteriors between A-NiTi and Cu-NiTi archwires |
|
Scientific Title of Study
|
Comparison of root resorption in lower anteriors between A-NiTi and Cu-NiTi archwires using cone beam computed tomography - A randomized clinical 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 |
Dr Komal Singh |
| Designation |
Post graduate student |
| Affiliation |
Bangalore Institute of Dental Sciences and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, Bangalore Institute of Dental Sciences and Hospital, 5/3 Hosur Main Road, Bangalore
Bangalore
KARNATAKA
560027
India |
| Phone |
6261186965 |
| Fax |
|
| Email |
singhkomalrathod@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjunath Hegde |
| Designation |
Head of Department, Department of Orthodontics and Dentofacial Orthopedics |
| Affiliation |
Bangalore Institute of Dental Sciences and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, Bangalore Institute of Dental Sciences and Hospital, 5/3 Hosur Main Road, Bangalore
Bangalore
KARNATAKA
560027
India |
| Phone |
9902878407 |
| Fax |
|
| Email |
21.hegde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Singh |
| Designation |
Post graduate student |
| Affiliation |
Bangalore Institute of Dental Sciences and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, Bangalore Institute of Dental Sciences and Hospital, 5/3 Hosur Main Road, Bangalore
KARNATAKA
560027
India |
| Phone |
6261186965 |
| Fax |
|
| Email |
singhkomalrathod@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Institute of Dental Sciences and Hospital, 5/3 Hosur Main Road, Bangalore - 560027 |
|
|
Primary Sponsor
|
| Name |
Bangalore Institute of Dental Sciences & Hospital |
| Address |
Bangalore Institute of Dental Sciences and Hospital, 5/3 Hosur Main Road, Bangalore - 560027 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Komal Singh |
Bangalore Institute of Dental Sciences and Hospital |
Deptartment of Orthodontics and Dentofacial Orthopedics, Bangalore Institute of Dental Sciences and Hospital, 5/3 Hosur Main Road, Bangalore - 560027
Bangalore
KARNATAKA |
91-6261186965
singhkomalrathod@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M262||Anomalies of dental arch relationship, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
A-NiTi archwire |
0.012-inch A-NiTi,0.014-inch A-NiTi,0.016-inch A-NiTi, 16X22 A-NiTi, 17X25 SS, 19X25 SS wires.
Duration is 6 months. |
| Intervention |
Cu-NiTi archwire |
0.013-inch Cu-NiTi,0.016-inch Cu-NiTi,14X25 Cu-NiTi,18X25 Cu-NiTi,19X25 SS wires.
Duration of intervention is 6 months |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Complete permanent dentition
2. Crowding and mandibular anterior region
3. Irregularity index(4mm - 9mm) |
|
| ExclusionCriteria |
| Details |
1. History of previous orthodontic treatment
2. Periodontal disease
3. Invisible too malposition
4. Lower incisor subjected to trauma
5. Systemic disease |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Extent of root resorption in lower anterior following alignment phase using A-NiTi and Cu-NiTi |
At baseline, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the extent of root resorption in lower anterior between A-NiTi & Cu-NiTi archwires |
At baseline, 3 months, 6 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)
|
31/10/2025 |
| 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="0"
Months="6"
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 study aims to evaluate root resorption in lower anteriors by comparing two initial aligning archwires, i.e., A-NiTi and Cu-NiTi archwires at the end of alignment phase using CBCT. The Null hypothesis of the study is that there is no significant difference in root resorption with A-NiTi arch wires and Cu-NiTi arch wires. |