| CTRI Number |
CTRI/2024/07/069789 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
28/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Changes in tongue position and airway volumes after twin block appliance therapy. |
|
Scientific Title of Study
|
Evaluation of Tongue Posture and Airway volumes following Twin Block Appliance Therapy in Growing skeletal class II patients- An Experimental 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 |
SAKSHI JAIN |
| Designation |
Junior resident |
| Affiliation |
Government Dental College and Hospital,Nagpur |
| Address |
104, Department of Orthodontics, Government Dental College and Hospita,Nagpur, Medical square, Nagpur
Nagpur MAHARASHTRA 440003 India |
| Phone |
7218524733 |
| Fax |
|
| Email |
jainsakshi224.sj@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jyoti Manchanda |
| Designation |
Associate professor |
| Affiliation |
Government dental college and hospital nagpur |
| Address |
104, Department of Orthodontics, Government Dental College and Hospita,Nagpur, Medical square, Nagpur Nagpur MAHARASHTRA 440003 India |
| Phone |
9423188175 |
| Fax |
|
| Email |
drjyotimadaan@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jyoti Manchanda |
| Designation |
Associate professor |
| Affiliation |
Government dental college and hospital nagpur |
| Address |
104, Department of Orthodontics, Government Dental College and Hospita,Nagpur, Medical square, Nagpur Nagpur MAHARASHTRA 440003 India |
| Phone |
9423188175 |
| Fax |
|
| Email |
drjyotimadaan@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics & Dentofacial Orthopaedics, Government Dental College and
Hospital Nagpur, Medical College Premises, Medical Square, Nagpur, Maharashtra 440003 |
|
|
Primary Sponsor
|
| Name |
Dr. Sakshi Jain |
| Address |
104, department of orthodontics and dentofacial orthopedics, government dental college and hospital, Nagpur. |
| Type of Sponsor |
Other [Self funded] |
|
|
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 SAKSHI JAIN |
Government Dental College and Hospital, Nagpur |
104, Department of Orthodontics, Government Dental College and Hospita,Nagpur, Medical square, Nagpur Nagpur MAHARASHTRA |
7218524733
jainsakshi224.sj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE GDC & H, NAGPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K149||Disease of tongue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Twin block therapy |
An informed consent will be taken from all patients parents or legal guardians, who agree to take part in study. Patients will be instructed to wear twin block for 24 hours.
Pre-treatment records –
1. Case history
2. Clinical examination
3. Study models
4. Lateral cephalograms
5. Orthopantomogram (OPG)
6. Intraoral and extraoral photographs
7. IOPA for MP3
8. CBCT
Appliance fabrication-
Twin block appliance will be fabricated according to the steps mentioned below and then delivered to patients.
Steps in Twin Block appliance fabrication-
1. Bite registration
2. Determining vertical dimension
3. Appliance designing and construction
4. Appliance delivery
5. Recall and reactivation of twin block
Post-treatment records-
Post-treatment records will be taken after achieving Class I molar relationship and post treatment records will be same as that of pre-treatment records
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Clinically:
No previous history of any orthodontic treatment.
Each subject with a full cusp class II or end-on molar relationship bilaterally with convex facial profile.
The overjet should be more than 4 mm.
Positive visual treatment objective (VTO)
Radiographically:
ANB angle more than 4 degrees with favourable growth pattern.
Subjects who are at accelerated phase of pubertal growth spurt (CVMI stage-3), MP3-FG and MP3- G stage.
|
|
| ExclusionCriteria |
| Details |
Syndromic cases.
Patients with following disorders –
A) Disorders of Bone metabolism.
B) Hepatobiliary disorders.
C) Systemic Inflammatory diseases.
Patients with compromised oral hygiene.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in tongue posture & airway volumes |
Baseline, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in airway volumes |
Baseline, 6 months |
|
|
Target Sample Size
|
Total Sample Size="22" Sample Size from India="22"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
21/07/2024 |
| 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 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
|
Myofunctional appliances are valuable tools in the armamentarium of orthodontics for the correction of altered form and function. Their mode of action on different sites of orofacial skeleton can control and modify the growth of mandible. Skeletal class II malocclusion being a prevalent condition can be corrected by these functional appliances in growing patients. Among these appliances Twin Block is the choice of appliance due to its versatility. The tongue is the most active muscular structure of the oropharyngeal system and is directly influenced by any modification in the dentoskeletal environment. After skeletal discrepancy is corrected, the tongue adapts within the altered position of the dental arches and can enhance post-functional stability. The tongue is a muscular organ that may be posteriorly positioned in a retrognathic mandible. With the use of a functional appliance such as Twin Block, posture of tongue can be improved, resulting in increased dimensions of the airways.
To our knowledge, there is limited literature evidence regarding changes in the posture of tongue after functional appliance therapy. Most of the studies are retrospective studies with two-dimensional imaging modality, which is not reliable due to magnification errors. There is no prospective study demonstrating the changes in tongue posture, using a three-dimensional (3D) imaging modality. Hence this study is designed to evaluate changes in tongue posture and airway volumes after twin block appliance therapy in growing skeletal class II patients using Cone Beam Computed Tomography. |