| CTRI Number |
CTRI/2025/03/083700 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Tongue volume and Mandibular Condylar position in Class I and Class II patients: A MRI Study |
|
Scientific Title of Study
|
The relationship between Tongue volume and Mandibular Condylar position in Class I and Class II patients: 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 debosmitaa sanyal |
| Designation |
MDS 2nd year student |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
department of orthodontics and dentofacial orthopedics,subharti dental college, subhartipuram, nh-58 delhi haridwar highway,meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
08209262361 |
| Fax |
|
| Email |
debosmitaasanyal53@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C Munish Reddy |
| Designation |
professor, department of orthodontics and dentofacial orthopedics |
| Affiliation |
subharti dental college and hospital |
| Address |
department of orthodontics and dentofacial orthopedics,subharti dental college, subhartipuram, nh-58 delhi haridwar highway,meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9690743050 |
| Fax |
|
| Email |
drmunishreddy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr C Munish Reddy |
| Designation |
professor, department of orthodontics and dentofacial orthopedics |
| Affiliation |
subharti dental college and hospital |
| Address |
department of orthodontics and dentofacial orthopedics,subharti dental college, subhartipuram, nh-58 delhi haridwar highway,meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9690743050 |
| Fax |
|
| Email |
drmunishreddy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Debosmitaa Sanyal
DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS, SUBHARTI DENTAL COLLEGE AND HOSPITAL, SWAMI VIVEKANAND SUBHARTI UNIVERSITY, SUBHARTIPURAM,NH-58, DELHI HARIDWAR BYPASS,MEERUT-250005,UTTAR PRADESH,INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Debosmitaa Sanyal |
| Address |
department of orthodontics and dentofacial orthopedics,subharti dental college and hospital,swami vivekanand subharti university,nh 58, delhi haridwar bypass road, meerut-250005, uttar pradesh, india |
| 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 Debosmitaa Sanyal |
subharti dental college and hosspital |
room no 7,department of orthodontics and dentofacial orthopedics,PG clinic,subharti dental college, subhartipuram, nh-58 delhi haridwar bypass road,meerut-250005
Meerut
UTTAR PRADESH |
8209262361
debosmitaasanyal53@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| university ethics committee (medical), swami vivekanand subharti university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients having class I and class II div 1 malocclusions |
| Patients |
(1) ICD-10 Condition: K006||Disturbances in tooth eruption, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.patients willingness to participate.
2.patients with either class I or class II maloclussion.
3.patients with overjet less than 6mm
|
|
| ExclusionCriteria |
| Details |
1.Metal implants or foreign bodies in the body that could interfere with the magnetic field or cause injury.
2.Claustrophobia or inability to remain still for the duration of the scan.
3.Severe obesity that exceeds the weight limit of the MRI machine.
4.Presence of certain medical devices or conditions that are incompatible with MRI, such as pacemakers, cochlear implants, or certain types of tattoos.
5.Inability to follow instructions or cooperate with the scanning procedure.
6.Presence of TMJ disorders or significant symptoms related to the temporomandibular joint.
7.History of TMJ surgery or significant trauma to TMJ.
8.Use of orthodontic appliance or previous orthodontic treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| correlation between tongue volume and the respective mandibular and condylar position in class I and class II patients using Magnetic Resonance Imaging. |
at beaseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess tongue volume in class I and class II div 1 patients |
1 year |
| to assess condylar position in class I and class II div 1 patients |
1 year |
| evaluation of changes in condylar position and tongue position on mandibular advancement in class II div 1 patients |
1 year |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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
|
The stomatognathic system comprises a highly integrated network of structures, including teeth, jaws, temporomandibular joints (TMJs), muscles of mastication, and associated soft tissues. This system is essential for chewing, swallowing, speech, and maintaining facial harmony. The relationship between tongue volume (TV), mandibular condylar position (MCP), and oral cavity capacity (OCC) is a crucial aspect of oral health. Variations in tongue volume and posture influence dental arch form and occlusion, with significant clinical implications for orthodontics, prosthodontics, and obstructive sleep apnea (OSA). Mandibular condylar position plays a critical role in jaw stability and TMJ health, and its relationship with tongue dynamics affects overall oral function. Changes in mandibular position due to treatments or disorders can impact tongue posture and oral volume, potentially leading to TMJ disorders or OSA. Understanding the interrelationship between TV, MCP, and OCC is critical for improving diagnostic accuracy and treatment outcomes in dental and craniofacial conditions. This study aims to explore these relationships and their implications for post-treatment stability, TMJ health, and overall patient quality of life. |