| CTRI Number |
CTRI/2026/03/106224 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Preventive
Screening
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Flexible or Rigid wire Which wire pulls back the upper front teeth at a faster rate in patients with upper and lower front teeth sticking out |
|
Scientific Title of Study
|
Comparison of Efficiency Between Reverse Curve of Spee Nickel Titanium and Stainless Steel Archwires in En Masse Retraction of Maxillary Anterior Teeth Using Sliding Mechanics in Moderate Anchorage Cases Randomized control 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 |
Vikas Dhasade |
| Designation |
2nd Year PG Trainee |
| Affiliation |
SCB Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopedics SCB Dental College and Hospital Manglabag Cuttack 753007 Orissa
Cuttack
ORISSA
753007
India |
| Phone |
9890944654 |
| Fax |
|
| Email |
dhasadevikas2312@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surya Kanta Das |
| Designation |
Professor and HOD |
| Affiliation |
SCB Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopedics SCB Dental College and Hospital Manglabag Cuttack 753007 Orissa
Cuttack
ORISSA
753007
India |
| Phone |
9861099237 |
| Fax |
|
| Email |
orthosuryakantadas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surya Kanta Das |
| Designation |
Professor and HOD |
| Affiliation |
SCB Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopedics SCB Dental College and Hospital Manglabag Cuttack 753007 Orissa
Cuttack
ORISSA
753007
India |
| Phone |
9861099237 |
| Fax |
|
| Email |
orthosuryakantadas@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vikas Dhasade |
| Address |
Department of Orthodontics and Dentofacial Orthopedics SCB Dental College and Hospital Manglabag Cuttack 753007 Orissa |
| 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 Surya Kanta Das |
SCB Dental College and Hospital |
Department of Orthodontics and Dentofacial Orthopedics SCB Dental College and Hospital Manglabag Cuttack 753007 Orissa
Cuttack
ORISSA |
9861099237
orthosuryakantadas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SCB DENTAL COLLEGE AND HOSPITAL CUTTACK |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K009||Disorder of tooth development, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 Retraction of maxillary anterior teeth using RCS NiTi archwire |
Initial leveling and alignmnet will be done then premolar extraction will be done and rate of space closure will be assessed before retraction and after 8 months of retraction using lateral cephalogram and study model |
| Comparator Agent |
Group 2 Retraction of maxillary anterior teeth using RCS stainless steel archwire |
Initial leveling and alignmnet will be done then premolar extraction will be done and rate of space closure will be assessed before retraction and after 8 months of retraction using lateral cephalogram and study model |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient exhibiting class I malocclusion with bimaxillary protrusion requiring extraction of first premolar teeth to manage a moderate anchorage scenario 2 Patient with crowding and spacing less than 5mm |
|
| ExclusionCriteria |
| Details |
1 Subject with a previous history of orthodontic treatment or trauma or endodontic treatment of maxillary anterior teeth 2 Pregnancy and syndromic patient
3 Subject with systemic disease or under long term medication like NSAIDs Bisphosphonates Corticosteroids
4 Subject exhibiting poor oral hygiene or active periodontal disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the rate of maxillary anterior teeth retraction |
To assess and compare the rate of space closure before and after 8 months of retraction in two different groups using RCS NiTi archwire and RCS stainless steel archwire |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1 To assess molar anchorage loss during retraction 2 To evaluate overjet and overbite changes 3 To evaluate the interincisal angle before and after retraction 4 To evaluate the change in inclination of anterior teeth 5 To evaluate change in occlusal plane |
To assess following changes before and after 8 months of retraction using lateral cephalogram and study model |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
06/04/2026 |
| 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="1"
Months="0"
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
|
This study compares rate of retraction of maxillary anterior teeth using RCS NiTi archwires in one group where RCS stainless steel archwires in another group initially pretreatment records will be taken like lateral cephalogram and study models then first premolar extraction will be done following initial leveling and alignment after eight months of retraction again records will be taken and statistical analysis will be done |