| CTRI Number |
CTRI/2026/02/105032 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Diagnostic
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Patient Pain and Time Outcomes with Different Archwires in Orthodontic Crowding Treatment |
|
Scientific Title of Study
|
Comparative evaluation of time taken and pain perception in unraveling of crowding using different archwires during orthodontic treatment an in vivo 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 |
Ekta Suman |
| Designation |
Post graduate student |
| Affiliation |
Kalka dental college |
| Address |
Department of orthodontics and dentofacial orthopedics room number 9
Kalka Dental college meerut
Meerut
UTTAR PRADESH
250103
India |
| Phone |
9743137638 |
| Fax |
|
| Email |
ektasumann@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shipra nagar |
| Designation |
head of the department |
| Affiliation |
kalka dental college,meerut |
| Address |
Department of Orthodontics ,kalka dental college,meerut
250103
uttar pradesh
Meerut
UTTAR PRADESH
250103
India |
| Phone |
9971822949 |
| Fax |
|
| Email |
shipray@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shipra nagar |
| Designation |
head of the department |
| Affiliation |
kalka dental college,meerut |
| Address |
Department of Orthodontics ,kalka dental college,meerut
250103
uttar pradesh
Meerut
UTTAR PRADESH
250103
India |
| Phone |
9971822949 |
| Fax |
|
| Email |
shipray@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of orthodontics and dentofacial orthopedics room number 9
Kalka dental college
Meerut
Uttar pradesh
India
Pin code 250103 |
|
|
Primary Sponsor
|
| Name |
Kalka dental college |
| Address |
Delhi meerut bypass road 250103 |
| Type of Sponsor |
Research institution |
|
|
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 |
| shipra nagar |
Kalka dental college |
Department of orthodontics and dentofacial orthopedics
Room number 9
Pin code 250103
Meerut
UTTAR PRADESH |
9971822949
shipray@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
malocclusion |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Coaxial NiTi Group super cable |
The study aims to compare the efficacy of different aligning archwires during the decrowding of mandibular anterior teeth it will also evaluate changes in intercanine width during the leveling and alignment phase in addition the study will compare the amount of time required for alignment and the pain perception experienced among all the groups as these outcomes will be assessed at time intervals of 4 weeks at 8 weeks and at 12 weeks |
| Intervention |
Superelastic NiTi
Copper NiTi
|
The study aims to compare the efficacy of different aligning archwires during the decrowding of mandibular anterior teeth it will also evaluate changes in intercanine width during the leveling and alignment phase in addition the study will compare the amount of time required for alignment and the pain perception experienced among all the groups as these outcomes will be assessed at time intervals of 4 weeks at 8 weeks and at 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patient with the age range of 15 to 30 years
patient has permanent dentition
mild crowding in mandibular anterior segment and having Littles irregularity index more than 3mm
eruption of all mandibular teeth which excluding 3rd molars with no spacing between them
No relevant medical history.
No previous orthodontic treatment.
No therapeutic intervention planned involving inter-maxillary, intra-maxillary, intraoral or extraoral appliances such as lingual holding arch expander during the study period.
|
|
| ExclusionCriteria |
| Details |
Patient with compromised periodontal health.
No previous history of any orthodontic treatment.
No missing or impacted tooth except 3rd molar.
Patien t with abnormality in shape, size and form of teeth.
Patient with any Craniofacial abnormality.
Patient on Non-steroidal anti-inflammatory drugs therapy.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of different aligning arch wires during decrowding of mandibular anterior teeth |
At the time of bonding 0 week at 4 th week 8 th week and at 12 th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare inter canine width |
At the time of Bonding 0 week at 4th week 8 th week and at 12th week |
| To compare amount of time taken and perception of pain |
At the time of Bonding 0 week at 4th week 8 th week and at 12th week |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
23/03/2026 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 12-02-2026 and end date provided 12-02-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Introduction The main goal of orthodontics is to identify and treat malocclusion in order to achieve a stable occlusion that is both aesthetically pleasing and functional proper tooth alignment is essential for general maintenance function and beauty as well as for maintaining and recovering oral health before nickel titanium niti arch wires were introduced orthodontists preferred stainless steel ss arch wires recent data indicate that the addition of cu to niti alloy results in a reduced transformation hysteresis a superelastic plateau and a more constant temperature
coaxial tubular superelastic niti wire was just released reduced treatment time improved spring back resistance to deformation and low force delivery are just a few of its many advantages over single stranded superelastic niti Aim and objectives To compare the efficacy of different aligning arch wires during decrowding of mandibular anterior teeth and to compare changes in inter canine width and to compare amount of time taken and perception of pain Method A total of 45 patients will be allocated for the study and will be divided into 3 groups group a superelastic niti group b cuniti and group c tubular suber cable depending upon the type of arch wires used during initial levelling and aligning and pretreatment records will made and the severity of crowding will be determined using littles irregularity index and bonding of the arch will be done and initial arch wire will be ligated at To at the time of bonding after bonding a reminder call will be given after 24hrs of ligation to patients for pain perception after 4 weeks patient will be recalled and same wire was religated intra oral records will be made again and little irregularity index pain perception will be recorded this procedure will be repeated on every 4 weeks until 12 week
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