| CTRI Number |
CTRI/2024/10/074547 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To know the effects of implant supported upper jaw expansion in young people on jaw joint using MRI. |
|
Scientific Title of Study
|
Evaluating the effects of mini-screw assisted rapid palatal expansion on temporomandibular joint in late adolescents : A magnetic resonance imaging 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 |
Dr Neha Bansal |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Maulana Azad Institute of Dental Sciences, MAMC complex, Near Bahadur Shah Zafar road, LNJP colony, New Delhi 110002
Central
DELHI
110002
India |
| Phone |
8800678312 |
| Fax |
|
| Email |
nehabansal528@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyank Rai |
| Designation |
Head of Department |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Room no. 412, 4th floor ,Maulana Azad Institute of Dental Sciences, MAMC complex, Near Bahadur Shah Zafar road, LNJP colony, New Delhi 110002
Central
DELHI
110002
India |
| Phone |
9654700965 |
| Fax |
|
| Email |
priyankraibraces@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Bansal |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
4th floor ,Maulana Azad Institute of Dental Sciences, MAMC complex, Near Bahadur Shah Zafar road, LNJP colony, New Delhi 110002
Maulana Azad Institute of Dental Sciences, MAMC complex, Near Bahadur Shah Zafar road, LNJP colony, New Delhi 110002
Central
DELHI
110002
India |
| Phone |
8800678312 |
| Fax |
|
| Email |
nehabansal528@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Institute of Dental Sciences, Mirdard Marg, Bahadur Shah Zafar Marg, LNJP Colony, New Delhi- 110002 |
|
|
Primary Sponsor
|
| Name |
Dr. Neha Bansal |
| Address |
Flat no. 12 Sector A6, Pocket 7, DDA Flats, Narela, Delhi- 110040 |
| Type of Sponsor |
Other [self-sponsored] |
|
|
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 Neha Bansal |
Maulana Azad Institute of Dental Sciences |
Room no. 412, 4th floor, Maulana Azad Institute of Dental Sciences, MAMC complex, Near bahadur shah Zafar Marg, LNJP Colony
Central
DELHI |
8800678312
nehabansal528@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Maulana Azad Institute of Dental Sciences |
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 |
Miniscrew-assisted rapid palatal expansion |
In this group patients will be selected on the basis of inclusion and exclusion criteria and expansion of maxilla will be done with miniscrew assisted rapid palatal expander device and its effects on TMJ will be seen by taking MRI before placement of device and after removal of device following expansion of maxilla |
| Comparator Agent |
Untreated control group |
In this group also patients will be taken on the basis of inclusion and exclusion criteria and two MRIs will be taken at an interval of 6 months and no intervention will be given. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects in late adolescence Cervical vertebrae
maturation stage less than 5 assessed through
lateral cephalogram
2. Unilateral or bilateral posterior crossbite
3. Maxillary transverse deficiency.
|
|
| ExclusionCriteria |
| Details |
1. Patients with systemic problems and under
medication
2. Poor oral hygiene patients with physical and
psychological limitations
3. Craniofacial anomalies
4. Temporomandibular joint anomalies or any previous trauma to TMJ
•Previous orthodontic treatment.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine change in position of mandibular condyles on MRI assessment at the end of treatment in intervention group. |
Change in position of mandibular condyles will be assessed after a retention period of 3 months after attaining expected expansion of maxillary bone. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any abnormality occurring in TMJ due to treatment |
Pre-treatment
Post-treatment |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/10/2024 |
| 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="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
|
To evaluate the effects of mini-screw assisted rapid palatal expansion (MARPE) on temporomandibular joint (TMJ) in late adolescent subjects using magnetic resonance imaging (MRI). |