| CTRI Number |
CTRI/2023/08/056479 [Registered on: 14/08/2023] Trial Registered Prospectively |
| Last Modified On: |
01/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of articular disc in asymptomatic and symptomatic temporomandibular disorders with MR t2 mapping technique. |
|
Scientific Title of Study
|
Evaluation of articular disc using MR-cartigram in asymptomatic and symptomatic temporomandibular disorders |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aparna S |
| Designation |
Post graduate |
| Affiliation |
SRM dental college |
| Address |
SRM dental college, Bharathi salai, Ramapuram, Chennai- 600089
Chennai
TAMIL NADU
600089
India |
| Phone |
09444812584 |
| Fax |
|
| Email |
appuaparna1511@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuradha G |
| Designation |
professor and Head of the department |
| Affiliation |
SRM dental college |
| Address |
SRM dental college, Bharathi salai, Ramapuram, Chennai- 600089
Chennai
TAMIL NADU
600089
India |
| Phone |
09444812584 |
| Fax |
|
| Email |
anug77@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Aparna S |
| Designation |
Post graduate |
| Affiliation |
SRM dental college |
| Address |
SRM dental colleg, Bharathi salai, Ramapuram, Chennai-600089
Chennai
TAMIL NADU
600089
India |
| Phone |
09444812584 |
| Fax |
|
| Email |
appuaparna1511@gmail.com |
|
|
Source of Monetary or Material Support
|
| out patients, department of oral medicine and radiology.
SRM dental college, bharathi salai, ramapuram, chennai-600089 |
|
|
Primary Sponsor
|
| Name |
Aparna S |
| Address |
Plot no 11, madha nagar extension v, madhanandapuram, chennai-125 |
| 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 |
| Aparna S |
SRM dental college |
SRM dental college, Deparment of oral medicine, Room no 1, Bharathi salai, Ramapuram, Chennai-600089
Chennai
TAMIL NADU |
9444812584
appuaparna1511@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Dental College, Ramapuram Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M241||Other articular cartilage disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Group A
Patients who are willing for the study
2.Patients above 18 years of age
3.Patients with temporomandibular joint disorders under RDC criteria is included.
4. Patients with symptoms of pain along with clicking, deviation during jaw movement, pain and difficulty in opening the mouth, pain in pre auricular area, and spreading to surrounding areas.
Group B
1.Patients who are willing for the study
2.Patients above 18 years of age
3.Patients with temporomandibular joint disorders under RDC criteria is included.
3.patients with temporomandibular disorders without pain but with symptoms of clicking, deviation while opening and closing the mouth, locking of the jaw while opening the mouth
Group C
1. Patients who are willing for the study
2. Patients above 18 years of age
3.Healthy volunteers without any symptoms of temporomandibular joint disorders
|
|
| ExclusionCriteria |
| Details |
1. Patients under 18 years of age
2. Pregnant and lactating patients
3. MRI is contraindicated in patients with pace makers, metallic implants, aneurysmal brain clips, metallic intra ocular foreign bodies, cochlear implants, claustrophobic patients.
4. Physically challenged and mentally retarded persons
5. Obese patients with more than 150 kgs who doesn’t fit in the MRI machine.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnosis of early changes in the articular cartilage of TMJ in patients with TMJ disorders |
4-8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Diagnosis of early changes in the articular cartilage of TMJ in TMJ disorder patients. |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="39"
Sample Size from India="39"
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)
|
25/08/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Clinical evaluations and imaging of the temporomandibular joint are crucial for the diagnosis and management of temporomandibular disorders (TMD). MR imaging has recently been acknowledged as the gold standard imaging technique of choice in the investigation of TMJ dysfunction. The MR cartigram, a T2 mapping technique that analyses the structural components of articular cartilage and reveals biochemical parameters and structural changes by measuring the T2 transverse relaxation time, was utilised in earlier research to assess the early stages of cartilage tissue degradation. T2 mapping, also known as T2 value imaging, is a quantitative imaging technique that has been efficaciously used to identify degenerated cartilage in the knee joint, femoral condyle, and intervertebral disc by using a T2 relaxation time as an auxiliary indicator to reflect the water and collagen contents. T2 mapping was shown to be feasible in the temporomandibular joint. Our study is designed to diagnose the early changes in the cartilage in asymptomatic and symptomatic temporomandibular disorder patients using MR cartigram.
|