| CTRI Number |
CTRI/2025/03/083011 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
COMPARATIVE EVALUATION OF ALIGNMENT EFFICIENCY OF THREE DIFFERENT ARCHWIRES IN RELIEVING MANDIBULAR ANTERIOR CROWDING: A RANDOMISED CLINICAL STUDY |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF ALIGNMENT EFFICIENCY OF NICKEL TITANIUM,COPPER NICKEL TITANIUM AND GUMMETAL ARCHWIRES IN RELIEVING MANDIBULAR ANTERIOR CROWDING:A RANDOMISED 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 |
ANBUMUHIL T R |
| Designation |
POST GRADUATE |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE, BENGALURU |
| Address |
ROOM NO 6,GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE, NEW THARAGURPET,VICTORIA HOSPITAL CAMPUS,KALASIPALYA,BENGALURU- 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
8667828836 |
| Fax |
|
| Email |
dr.anbumuhil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.NAUSHEER AHMED |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE, BENGALURU |
| Address |
ROOM NO 6,GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE, NEW THARAGURPET,VICTORIA HOSPITAL CAMPUS,KALASIPALYA,BENGALURU- 560002
KARNATAKA
560002
India |
| Phone |
9845176230 |
| Fax |
|
| Email |
dr.nausheer.ahmed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANBUMUHIL T R |
| Designation |
POST GRADUATE |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE, BENGALURU |
| Address |
ROOM NO 6,GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE, NEW THARAGURPET,VICTORIA HOSPITAL CAMPUS,KALASIPALYA,BENGALURU- 560002
KARNATAKA
560002
India |
| Phone |
8667828836 |
| Fax |
|
| Email |
dr.anbumuhil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government dental college and research institute , bengaluru-560002, karnataka , India |
|
|
Primary Sponsor
|
| Name |
Government dental college and research institute, bemgaluru |
| Address |
Victoria hospital campus , kalaispalayam , bengaluru -560002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DRANBUMUHIL T R |
GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE, BENGALURU |
ROOM NO 6,GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE,BENGALURU
Bangalore
KARNATAKA |
8667828836
dr.anbumuhil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE , GDCRI BENGALURU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Angles class I malocclusion with lower anterior crowding |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 - 0.014inch nickel titanium archwire |
Treatment of moderate lower anterior crowding using 0.014 inch round nickel titanium archwire
|
| Comparator Agent |
Group 2 - 0.014 inch copper nickel titanium archwire |
Treatment of moderate lower anterior crowding using 0.014 inch round copper nickel titanium archwire |
| Comparator Agent |
Group 3 - 0.014 inch gummetal archwire |
Treatment of moderate lower anterior crowding using 0.014 inch round Gummetal archwire |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
Moderate mandibular anterior crowding
Class I malocclusion
Non extraction treatment in lower arch
Eruption of all permanent teeth with no spacing between them excluding third molars
Full arch mechanics with preadjusted edgewise appliance , MBT system |
|
| ExclusionCriteria |
| Details |
Periodontally compromised subjects
Subjects with previous history of orthodontic treatment
Subjects with relevant medical history
Subjects with recent history of intake of drugs such as NSAIDs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Calculate the amount of crowding relieved by each archwire (nickel titanium, copper nickel titanium and gummetal) in the mandibular anterior region using data obtained at baseline , 4th , 8th and 12th week |
at baseline , 4th week , 8th week and 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare alignment efficiency of nickel titanium , copper nickel titanium & gummetal archwires in relieving moderate mandibular anterior crowding |
at baseline , 4th week ,8th week & 12th week |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
31/03/2025 |
| 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="1"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Previous studies have been conducted to test the efficiency of gummetal archwires in comparison to nickel titanium archwires in case of mild to moderate mandibular anterior crowding. There are no studies comparing alignment efficiency of gummetal archwire and copper nickel titanium archwire so far. Hence this study will be done to compare and evaluate the alignment efficiency of Nickel titanium , Copper nickel titanium and gummetal archwires in relieving mandibular anterior crowding |