| CTRI Number |
CTRI/2024/02/062408 [Registered on: 07/02/2024] Trial Registered Prospectively |
| Last Modified On: |
07/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of bony changes in mouth joint disorders using saliva |
|
Scientific Title of Study
|
Comparative Evaluation of Condylar Changes in Temporomandibular Joint Disorder Patients Assessed by Salivary Biomarkers MMP3, IL1Î’, and PAI1 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gibi Babu Philip |
| Designation |
Associate Professor |
| Affiliation |
Azeezia Dental College |
| Address |
Room No 3,Ground Floor, Dept of Prosthodontics,
Azeezia Dental College, Velichikkala - Meeyannoor Rd, Adichanalloor
Kollam
KERALA
691573
India |
| Phone |
8606073792 |
| Fax |
|
| Email |
drgibi.philip@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Alex Mathews Muruppel |
| Designation |
Professor |
| Affiliation |
Rajas Dental College |
| Address |
Room No 8, Ground Floor
Dept of Prosthodontics,
Rajas Dental College, Kavalkinaru junction.
Tirunelveli
TAMIL NADU
627105
India |
| Phone |
7034671873 |
| Fax |
|
| Email |
alexmuruppel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Alex Mathews Muruppel |
| Designation |
Professor |
| Affiliation |
Rajas Dental College |
| Address |
Room No 8, Ground Floor
Dept of Prosthodontics,
Rajas Dental College, Kavalkinaru junction.
Tirunelveli
TAMIL NADU
627105
India |
| Phone |
7034671873 |
| Fax |
|
| Email |
alexmuruppel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Azeezia Dental College, Velichikkala - Meeyannoor Rd, Adichanalloor, Kerala 691573 |
|
|
Primary Sponsor
|
| Name |
Gibi Babu Philip |
| Address |
Ligi Villa, Bharathipuram PO,
Anchal, Kollam 691312 |
| 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 Alex Mathews Muruppel |
Azeezia Dental College |
Department of Prosthodontics, Room No 3,
Azeezia Dental College, Velichikkala Meeyannoor Rd, Adichanalloor, Kerala 691573
Kollam
KERALA |
7034671873
alexmuruppel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AzeeziaEthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M255||Pain in joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Patients on clinical examination who met RDC TMD criteria I
Female patients
|
|
| ExclusionCriteria |
| Details |
Congenital craniofacial disorders
Previous treatment for TMJ disorders
Previous orthodontic treatments
History of trauma to the TMJ area
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Compare the level of MMP3, IL1β, PAI1 in TMD patients before
and after treatment.
Compare the level of MMP3, IL1β, ,PAI1 in healthy and TMD patients
|
5 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the level of MMP3, IL1β,PAI1 in healthy patients
To determine the level of MMP3, IL1β,PAI1 in TMD patients |
1 month |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
04/03/2024 |
| 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="2"
Days="1" |
|
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
|
Temporomandibular joint disorder is commonly diagnosed with radiographic imaging modalities like Computed Tomography (CT), Cone Beam Computed Tomography (CBCT), Orthopantomagram (OPG) etc. The most popular among these is CBCT. Considerable amount of bony loss (30%) should happen in order to become visible through radiograph , so we need to have new diagnostic approaches which might help in early detection of bony disorders. Biomarkers, which are naturally occurring biological molecule found in blood, saliva or other body fluids can be used. They reveal inflammation, angiogenesis and tissue destruction that correlates with bone resorption and repair. Assessing salivary biomarkers will show real time changes and also predict future resorption which helps us to start with treatment as early as possible. |