| CTRI Number |
CTRI/2025/03/083513 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Radiographic changes in the TMJ and mandible in children with a forwardly positioned lower jaw using a new appliance. |
|
Scientific Title of Study
|
Three-Dimensional Evaluation Of The Changes In Glenoid Fossa And The Mandible In Children With Class III Malocclusion Using Modified Reverse Twin Block Appliance |
| 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 Nivetha Manoharan |
| Designation |
First Year MDS Post graduate student |
| Affiliation |
A B Shetty Memorial Institute of Dental Sciences |
| Address |
Department of Pediatric and Preventive Dentistry, A B Shetty Memorial Institute of Dental Sciences, Medical Sciences
Complex, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9790887167 |
| Fax |
|
| Email |
nivemanoharan2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajmohan Shetty |
| Designation |
Professor |
| Affiliation |
A B Shetty Memorial Institute of Dental Science |
| Address |
Department of Pediatric and Preventive Dentistry, A B Shetty Memorial Institute of Dental Sciences, Medical Sciences
Complex, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448253296 |
| Fax |
|
| Email |
rajmohanshetty4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nivetha Manoharan |
| Designation |
First Year MDS Post graduate student |
| Affiliation |
A B Shetty Memorial Institute of Dental Sciences |
| Address |
Department of Pediatric and Preventive Dentistry, A B Shetty Memorial Institute of Dental Sciences, Medical Sciences
Complex, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9790887167 |
| Fax |
|
| Email |
nivemanoharan2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| A B Shetty Memorial Institute of Dental Sciences, Medical Sciences Complex, Deralakatte, Mangalore 575018
|
|
|
Primary Sponsor
|
| Name |
Dr Nivetha Manoharan |
| Address |
Room No:15, 4th Floor, Department of Pediatric and Preventive
Dentistry, AB Shetty Memorial Institute of Dental Sciences,
Deralakatte, Mangaluru-575018 Karnataka, India |
| Type of Sponsor |
Other [self ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| not applicable |
not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nivetha Manoharan |
A B Shetty Memorial Institute Of Dental Sciences |
Room No:15, 4th floor,
Department of Pediatric
and Preventive
Dentistry, AB Shetty
Memorial Institute of
Dental Sciences ,
Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA |
9790887167
nivemanoharan2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe, AB Shetty Memorial Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K03||Other diseases of hard tissues ofteeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
changes in the glenoid fossa and mandible before and after the appliance wear. |
changes in the glenoid fossa and mandible before and 12- 14 months after the appliance wear using Cone Beam Computed Tomography imaging |
| Intervention |
Modified Reverse Twin Block Appliance |
Modified Reverse Twin Block Appliance given to class III malocclusion. Appliance is cemented on the upper and lower dental arches. Duration of the wear for the first phase of the treatment is 12- 14 months. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
1) 15 children in the age group of 10-13 years.2) Young growing patients exhibiting class III malocclusion (CVM stage 1-4). 3)Wits appraisal of -1mm to -5mm. 4)Anterior crossbite or incisor end to end relationship. 5) class III molar relationship. 6) Children whose parent/legal guardian have given consent. |
|
| ExclusionCriteria |
| Details |
1) Medically and physically compromised children.
2) with existing temporomandibular joint disorders.
3) Patients requiring surgical intervention for class III correction ( Wits appraisal reading greater than -5mm)
4) Children /parents not consenting to participate in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Three dimensional evaluation of the changes in glenoid fossa and the mandible using CBCT. |
Baseline and 12-14 months after appliance wear. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| changes in the mandibular ramus length |
Baseline and 12-14 months after appliance wear. |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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 2 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/05/2025 |
| 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 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 - NO
|
|
Brief Summary
|
Class III malocclusion represents a complex three dimensional facial skeletal imbalance between maxillary and mandibular growth along with varying degrees of dentoalveolar and soft tissue compensations. Various interceptive orthodontic treatments for class III malocclusion include facemask, reverse twin block, tandem traction bow appliance , skeletal anchorage system and chin cup. The Reverse Twin Block has proven to be a simple, comfortable, well tolerated and eflicient functional appliance for the correction of developing Class III malocclusions during mixed dentition. However, the eflects of this appliance are primarily limited to the dentition. Skeletal changes are limited to slight downward and backward rotation of the mandible. Another treatment modality for class malocclusion is the Bone Anchored Maxillary Protraction (BAMP), but the surgical intervention for the placement of miniplates makes the patient apprehensive. To overcome these disadvantages a modification of the conventional Reverse Twin Block was designed combining the following principles BAMP HYRAX FACEMASK REVERSE TWIN BLOCK In the modified design of the reverse twin block appliance, along with upper and lower bite blocks of conventional reverse twin block appliance, several other components are added Rapid Maxillary Expansion Device (Hyrax Screw) Hooks placed in the upper molar region in the upper bite block and in between the lateral incisor and canine, in the lower bite block. Intra-oral elastics are used engaging both the hooks on either side. (The force applied passes through the Centre of Resistance of Maxilla and is at 30 degrees to the occlusal plane). Various studies have shown changes in the TMJ following chincup. BoneAnchored Maxillary Protraction |BAMP), Facemask therapy. Though TMJ can be visualized in 2D cephalometry, superimpositions have some limitations with respect to accuracy and reliability and superimposition on 3D images have been used to provide more reliable infornation.
To date, however, there is a lack of knowledge on the changes occumring in the mandible and glenoid fossa following the conventional or modified reverse twin block therapy Hence, in this study we sought to evaluate the effects of the modified reverse twin block appliance on the mandible and the glenoid fossa in class III subjects using Cone Beam Computed Tomography.
15 children with class III malocclusion in the age group of 10-13 years reporting to the Out Patient Department of the Department of Pediatric and Preventive Dentistry at A B Shetty Institute of Dental Sciences, Deralakatte will be included in the study. A detailed case history, clinical examination and cephalometric analysis will be done to confirm the skeletal pattern of the patient.
child before the commencement of the study. Pre-operative CBCT will be taken before delivering the Modified reverse twin block appliance. All instructions regarding the appliance like changing of the intermaxillary elastics daily and the activation of the screw will be given to the patient. follow up CBCT will be recorded after 12-14 months of appliance wear. Data will be collected and statistically analyzed. |