| CTRI Number |
CTRI/2025/07/090719 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of clinical features and shapes and sizes of the jaw joint using radiographs in patients with and without jaw joint disorders. |
|
Scientific Title of Study
|
Morphometric evaluation of temporomandibular joint using cone-beam computed tomography and association of clinical dysfunction index in patients with temporomandibular disorders |
| 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 Shruthi Hegde |
| Designation |
Reader |
| Affiliation |
A B Shetty Memorial Institute of Dental Sciences affiliated to Nitte (Deemed to be University) |
| Address |
Department of Oral Medicine and Radiology,
A B Shetty Memorial Institute of Dental Sciences,
Nitte (Deemed to be University),
Deralakatte,
Mangaluru.
Deralakatte, Mangaluru,
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9901321299 |
| Fax |
|
| Email |
drshruthihegde@nitte.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidya Ajila |
| Designation |
Professor and Head |
| Affiliation |
A B Shetty Memorial Institute of Dental Sciences affiliated to Nitte (Deemed to be University) |
| Address |
Department of Oral Medicine and Radiology,
A B Shetty Memorial Institute of Dental Sciences,
Nitte (Deemed to be University),
Deralakatte,
Mangaluru.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9483336155 |
| Fax |
|
| Email |
drvidyaajila@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruthi Hegde |
| Designation |
Reader |
| Affiliation |
A B Shetty Memorial Institute of Dental Sciences |
| Address |
Department of Oral Medicine and Radiology,
A B Shetty Memorial Institute of Dental Sciences,
Nitte(Deemed to be University),
Deralakatte,
Mangaluru.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9901321299 |
| Fax |
|
| Email |
drshruthihegde@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| A B Shetty Memorial Institute of Dental Sciences,
Nitte (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India 575018
|
|
|
Primary Sponsor
|
| Name |
Dr Shruthi Hegde |
| Address |
Department of Oral Medicine and Radiology, A B Shetty Memorial Institute of Dental Sciences,
Nitte (Deemed to be University), Dearalakatte, Mangaluru 575018
|
| 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 Shruthi Hegde |
A B Shetty Memorial Institute of Dental Sciences |
Department of Oral Medicine and Radiology, A B Shetty Memorial Institute of Dental Sciences, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA |
9901321299
drshruthihegde@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CENTRAL ETHICS COMMITTEE, NITTE (Deemed to be University) |
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 |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria for Study Group
1.Patients reporting with complaint of pain in the TMJ region or muscles of mastication and diagnosed with Temporomandibular joint disorders(TMD) according to the Research Diagnostic Criteria (RDC/TMD).
2.Patients who are willing to participate in the study.
3. Patients in the age group of 18 to 60 years
Inclusion criteria for control group
1.Patients without Temporomandibular joint disorders (Helkimo clinical index =0) and require Cone beam computed tomography(CBCT) for the diagnosis and treatment planning
2.Patients who are willing to participate in the study
3.Patients in the age group of 18 to 60 years
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria for Study Group
1.Patients with a history of trauma, TMJ surgery, congenital abnormalities, neuromuscular disorders, patients presenting with a history of any tumour or growth in the orofacial region that can influence the morphology of the condyle or affect the dimensions of the joint spaces
2. Pregnancy
3. Patients with CBCT images having inadequate clarity or resolution
Exclusion criteria for control group
1.Patients with a history of trauma, TMJ surgery, congenital abnormalities, neuromuscular disorders, patients presenting with a history of any tumour or growth in the orofacial region that can influence the morphology of the condyle or affect the dimensions of the joint spaces
2.Patients with history of systemic arthritis
3.Images with inadequate field of view (FOV)
4.Patients with CBCT images having inadequate clarity or resolution
5.Presence of degenerative changes in the CBCT images
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate difference in the morphology and morphometric features of the temporomandibular joint in patients with and without temporomandibular disorders |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare & evaluate the clinical, radiographic & morphometric features with types of temporomandibular disorders |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="276"
Sample Size from India="276"
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)
|
28/07/2025 |
| 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) |
Open to Recruitment |
|
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
|
Present study will be conducted to evaluate the
morphometric parameters of the patients with and without TMD and to compare the
morphometric features with the clinical dysfunction index.
Research Question
Do morphometric features of TMJ differ in
patients with TMD and without TMD and do
morphometric features have an association with
the clinical severity of TMD?
Methodology
A standard protocol will be followed for the
diagnosis of the new patients reporting to the department. Patients will be
explained in detail about the study, and informed consent will be obtained from
the patients willing to participate. The study will be comprised of a total of
276 patients. The control group (Group I) includes 138 patients without TMD and
the study group (Group II) includes 138 patients with TMD. Selective sampling
method will be used to ensure similar age and sex distribution in the control
group as the study group in order to avoid any arbitrary effect on study
results. Study group will be further categorized into 3 subgroups according
to the Research Diagnostic Criteria. Patient demographic details, history and clinical
signs and symptoms recording will be carried out in data collection forms. The
patients will be evaluated according to clinical dysfunction index. Depending
on the total score obtained, patients will be classified as having a clinical
Di between 0 and 4. CBCT analysis will be carried out for 552 joints (276 right
side and 276 left side joints of 276 patients). The morphologic features and morphometric
parameters such as mandibular condyle shape, glenoid fossa shape, condylar bony
changes, condylar height, condylar width, anterior joint space, posterior joint
space, superior joint space, glenoid fossa roof thickness, glenoid fossa width,
glenoid fossa depth will be evaluated and analysed in the study. |