| CTRI Number |
CTRI/2024/02/062720 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational and analytical study to evaluate hyoid bone position, airway dimension, and psychological status in TMD patients |
|
Scientific Title of Study
|
Comparative evaluation and correlation of hyoid bone position, airway dimension and psychological status in cases with Class II (vertical) temporomandibular disorder cases and Class II (horizontal) TMD cases as compared to Class I Non-temporomandibular disorder cases |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aathira Surendran K |
| Designation |
Postgraduate student |
| Affiliation |
Sharad Pawar Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics Sharad Pawar Dental College and Hospital
Datta Meghe Institute of Higher Education Research Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9549748175 |
| Fax |
|
| Email |
aathirasurendrank@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aathira Surendran |
| Designation |
Postgraduate student |
| Affiliation |
Sharad Pawar Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics
Datta Meghe Institute of Higher Education Research Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9549748175 |
| Fax |
|
| Email |
aathirasurendrank@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sunita Shrivastav |
| Designation |
Professor |
| Affiliation |
Sharad Pawar Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics Sawangi
Datta Meghe Institute of Higher Education Research Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
7743900590 |
| Fax |
|
| Email |
sunitashrivastavphd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sharad Pawar Dental College and Hospital Datta Meghe Institute of Higher Education and Research Sawangi Wardha |
|
|
Primary Sponsor
|
| Name |
Sharad Pawar Dental College and Hospital |
| Address |
Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha |
| 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 |
| Aathira Surendran |
Sharad pawar dental college and hospital |
Department of orthodontics and dentofacial Orthopaedics, Datta Meghe Institute of Higher Education and Research Sawangi(Meghe)
Wardha
MAHARASHTRA |
9549748175
aathirasurendrank@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Datta Meghe Institute of Higher Education & Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients with temporomandibular disorder |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Class I non-temporomandibular cases |
Class II vertical temporomandibular cases and Class II horizontal temporomandibular cases will be compared with Class I non-temporomandibular cases. |
| Intervention |
Class II vertical temporomandibular cases and Class II horizontal temporomandibular cases |
Class II vertical temporomandibular disorder cases and class II horizontal temporomandibular disorder cases will be evaluated based on helkimo index and warwick edinburgh scale for psychological status. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Class I malocclusion (diagnosed using cephalometric analysis)
Patients with Class II (vertical) malocclusion and TMD.
Patients with Class II (horizontal) malocclusion and TMD.
All permanent teeth present.
Adult age group.
|
|
| ExclusionCriteria |
| Details |
Non - TMD class II (vertical) cases.
Non - TMD class II (horizontal) cases.
Class III malocclusion cases.
Patients with myofacial pain dysfunction and myalgia.
Previous intervention with TMJ surgery or trauma to TMJ.
Patients with bony disorders.
Patients had a history of systematic diseases or psychiatric illness.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluating the hyoid bone position, airway dimensions, and psychological status of TMD patients can provide valuable information for orthodontists to develop effective treatment plans that address the complex interactions between TMD, airway obstruction, and psychological distress. By taking a comprehensive approach to TMD treatment, orthodontists can improve patient outcomes and quality of life. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate hyoid bone position, airway dimension and psychological status in Class I (Non- TMD) cases, Class II (Vertical) TMD cases, Class II (Horizontal) TMD cases.
2. To compare hyoid bone position, airway dimension and psychological status in Class II (Vertical) TMD with Class II (Horizontal) TMD cases and Class I (Non-TMD) cases.
3. To co-relate the variation in hyoid bone position, airway dimension and psychological status with skeletal pattern.
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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)
|
15/02/2024 |
| 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="0"
Months="6"
Days="30" |
|
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
|
The temporomandibular disorder (TMD) encompasses several clinical manifestations which is characterized by pain and dysfunction of the masticatory muscles and the temporomandibular joint (TMJ) . TMD has a complex aetiology, although there are likely multiple factors at play, including biomechanical, neuromuscular, psychological, and biological factors. TMD can be associated with a wide range of symptoms, including sleep disorders, airway obstruction, and psychological distressTMD is a physical and psychological illness that causes exhaustion, sleep problems, anxiety, and sadness. TMD patients often experience pain, which can affect their quality of life, sleep, and mood. With the stimulation of the sympathetic nervous system, psychological issues (such as depression and anxiety) can stress the TMJ and masticatory muscles. Also, contemporary research has validated the link between psychological dysfunctions and chronic pain therefore, assessing the psychological status of TMD patients can help orthodontists better understand the impact of TMD on patients’ overall well-being and tailor treatment plans accordingly. |