| CTRI Number |
CTRI/2023/10/059238 [Registered on: 27/10/2023] Trial Registered Prospectively |
| Last Modified On: |
18/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of effects of Pre-orthodontic Trainer and Twin Block appliance in growing patients with a backwardly placed lower jaw |
|
Scientific Title of Study
|
Clinical and cephalometric comparison of Pre-orthodontic Trainer and Twin Block appliance in growing patients with a retropositioned mandible in skeletal Class II malocclusion: A randomised clinical trail |
| 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 Aishwarya Thorat |
| Designation |
Post graduate student |
| Affiliation |
Rural Dental College, Loni |
| Address |
Rural Dental College, Department of Orthodontics and Dentofacial Orthopedics, Pravara Institute of Medical Sciences, Loni, Ahmednagar
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
8446672505 |
| Fax |
|
| Email |
thorataishwarya201@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Manerikar |
| Designation |
Professor |
| Affiliation |
Rural Dental College, Loni |
| Address |
Rural Dental College, Department of Orthodontics and Dentofacial Orthopedics, Pravara Institute of Medical Sciences, Loni, Ahmednagar
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9764831633 |
| Fax |
|
| Email |
docravi.m@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravindra Manerikar |
| Designation |
Professor |
| Affiliation |
Rural Dental College, Lon |
| Address |
Rural Dental College, Department of Orthodontics and Dentofacial Orthopedics, Pravara Institute of Medical Sciences, Loni, Ahmednagar
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9764831633 |
| Fax |
|
| Email |
docravi.m@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rural Dental College, Loni, Ahmednagar |
|
|
Primary Sponsor
|
| Name |
Pravara Institute of Medical Sciences Loni |
| Address |
Rural Dental College, Loni, Ahmednagar |
| 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 |
| Dr Aishwarya Thorat |
Rural Dental College, Loni |
Department of Orthodontics and Dentofacial Orthopedics, Rural Dental College, Loni, Ahmednagar
Ahmadnagar
MAHARASHTRA |
8446672505
thorataishwarya201@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC PIMS DU Loni |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pre-Orthodontic Trainer |
Pre-Orthodontic Trainer is prescribed for correction of skeletal Class II correction |
| Comparator Agent |
Twin Block Appliance |
Twin Block appliance is usually prescribed for skeletal Class II correction |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1)Skeletal Class II patients with mandibular retroposition
2)Overjet more than 4mm
3)Angle ANB more than 4 degree
4)Growing patients (CVMI 1-4)
5)Patients whose parents/guardians willing to give written and informed consent to this study
6)Patients with no previous orthodontic treatment |
|
| ExclusionCriteria |
| Details |
1)Skeletal Class I malocclusion
2)Skeletal Class III malocclusion
3)Patients whose skeletal growth has completed
4)Patients with missing teeth
5)Patients with bone metabolic disorders
6)Patients with congenital deformity of orofacial structures or any craniofacial syndromes
7)Patients with chronic ulcers in oral cavity
8)Patients not showing compliance with the treatment
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Both the pre-orthodontic trainer and the twin block appliance will cause forward positioning of the mandible correcting the skeletal Class II malocclusion. |
The patients will be assessed after 12 months to compare the efficiency of the pre-orthodontic trainer and the twin block appliance. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Both the pre-orthodontic trainer and the twin block appliance will improve the soft tissue profile of the patient |
12 months |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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 4 |
|
Date of First Enrollment (India)
|
01/11/2023 |
| 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="2"
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
|
The aim of this study is to compare clinically and cephalometrically
the changes brought by use of preorthodontic trainer and twin block appliance
on both hard and soft tissues in patients with skeletal Class II relation with
mandibular retroposition.
AIMS:
The aim of this study is to evaluate and compare clinically
and cephalometrically the hard and soft tissue effects of preorthodontic
trainer and twin block appliance in patients with a retropositioned mandible in
skeletal Class II relationship.
OBJECTIVES:
1) To evaluate the pre and
post treatment effects of myofunctional trainer in patients with a retropositioned mandible in
skeletal Class II relationship.
2) To evaluate the pre and
post treatment effects of a conventional removable Twin Block in patients with a retropositioned mandible in
skeletal Class II relationship.
3) To compare clinically the
effect of myofunctional trainer and conventional removable twin block in patients with a retropositioned mandible in
skeletal Class II relationship.
4) To compare
cephalometrically the effect of myofunctional trainer and conventional
removable twin block in
patients with a retropositioned mandible in skeletal Class II relationship. 5) To evaluate and
compare the soft tissue changes of a conventional removable twin block and a
preorthodontic trainer in patients with a retropositioned mandible in
skeletal Class II relationship. |