| CTRI Number |
CTRI/2024/04/065094 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of change in front teeth between single wire and double wire space closure technique |
|
Scientific Title of Study
|
Evaluation of change in the anterior teeth between single wire and double wire retraction technique: A 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 |
Sharvari Mairal |
| Designation |
Junior Resident |
| Affiliation |
Faculty of Dental Sciences, IMS, Banaras Hindu University |
| Address |
Room no. 3, Department of Orthodontics, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9975483090 |
| Fax |
|
| Email |
sharvari35@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vipul Kumar Sharma |
| Designation |
Associate Professor |
| Affiliation |
Faculty of Dental Sciences, IMS, Banaras Hindu University |
| Address |
Room no.3, Department of Orthodontics Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9389460640 |
| Fax |
|
| Email |
vipulk.sharma1@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharvari Madhav Mairal |
| Designation |
Junior Resident |
| Affiliation |
Faculty of Dental Sciences, IMS, Banaras Hindu University |
| Address |
Room no.3, Department of Orthodontics Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9975483090 |
| Fax |
|
| Email |
sharvari35@gmail.com |
|
|
Source of Monetary or Material Support
|
| Floor no. 2, Room no. 3, Department of Orthodontics, Faculty of Dental Sciences, IMS, Banaras Hindu University |
|
|
Primary Sponsor
|
| Name |
Dr Sharvari Madhav Mairal |
| Address |
Orthodontic Division, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi |
| 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 Sharvari Mairal |
Banaras Hindu University |
Room no. 3, Department of Orthodontics, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH |
09975483090
sharvari35@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M264||Malocclusion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Duploslot brackets with double wire retraction |
Retraction of anterior segment using double wire retraction for 6 months |
| Comparator Agent |
Duploslot brackets with single wire retraction |
Retraction of anterior segment using single wire retraction for 6 months |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
23.00 Year(s) |
| Gender |
Female |
| Details |
1) Patients requiring first premolar extractions due to maxillary anterior teeth proclination
2) Minimal or no crowding in the maxillary and mandibular arch
3) Fully erupted permanent dentition
4) Good oral and general health |
|
| ExclusionCriteria |
| Details |
1) Systemic diseases or syndromes
2) Long term anti-inflammatory medication
3) Extraction of missing permanent teeth
4) History of previous orthodontic treatment
5) Parafunctional habits
6) Grossly decayed teeth
7) Any cases of facial asymmetry
8) Temporomandibular dysfunction |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the inclination of incisors post retraction of anterior teeth |
After 4 months and after 10 months from the start of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rate of tooth movement |
After 4 months & after 10 months of treatment |
| Anchorage loss |
After 4 months & after 10 months of treatment |
| Root resorption |
After 4 months & after 10 months of treatment |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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 is a randomized control study, in which patients are randomly allotted into control and intervention groups comparing various parameters during retraction of anterior teeth with single wire and double wire retraction technique. The study will be conducted at Unit of Orthodontics and dentofacial orthopedics, Faculty of Dental Sciences, BHU, Varanasi, India. Evaluation of inclination of incisors after retraction between the two groups is done as a primary outcome. Other factors such as rate of tooth movement, anchorage loss, amount of root resorption associated with anterior segment retraction are determined and assessed as a secondary outcome. |