CTRI Number |
CTRI/2021/07/035312 [Registered on: 30/07/2021] Trial Registered Prospectively |
Last Modified On: |
02/02/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Radiation Therapy Diagnostic |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
3 DIMENSIONAL IMAGING OF LOWER JAW JOINT IN TEETH GRINDING HABIT PATIENTS. |
Scientific Title of Study
|
ASSESMENT OF CONDYLAR OSSEOUS CHANGES IN PATIENTS WITH BRUXISM USING CONE BEAM COMPUTED TOMOGRAPHY |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr S Sarath kumar |
Designation |
Post Graduate |
Affiliation |
SRM INSTITUTE OF SCIENCE AND TECHNOLOGY |
Address |
NO:3/10,Room no:1
DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY,
SRM DENTAL COLLEGE, RAMAPURAM,
CHENNAI-600089.
Chennai TAMIL NADU 600089 India |
Phone |
9655015126 |
Fax |
|
Email |
sarathsrinivasan76@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr A KANNAN |
Designation |
Professor |
Affiliation |
SRM INSTITUTE OF SCIENCE AND TECHNOLOGY |
Address |
NO:3/10
DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY,
SRM DENTAL COLLEGE, RAMAPURAM,
CHENNAI-600089.
Chennai TAMIL NADU 600089 India |
Phone |
9655015126 |
Fax |
|
Email |
kannan_mds@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Dr S Sarath kumar |
Designation |
Post Graduate |
Affiliation |
SRM INSTITUTE OF SCIENCE AND TECHNOLOGY |
Address |
NO:3/10,Room no 1,
DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY,
SRM DENTAL COLLEGE, RAMAPURAM,
CHENNAI-600089.
Chennai TAMIL NADU 600089 India |
Phone |
9655015126 |
Fax |
|
Email |
sarathsrinivasan76@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
DrSARATH KUMAR |
Address |
NO:1/16A, 12th cross street venkateshwara nagar,Ramapuram,
Chennai-600089. |
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 |
DrAKANNAN |
SRM DENTAL COLLEGE |
N0:3/10A,Room no:1, DEPARTMENT OF ORAL MEDICINE AND RADIOLOG,SRM DENTAL COLLEGE,BHARATHI SALAI,RAMAPURAM,CHENNAI-600089. Chennai TAMIL NADU |
9655015126
sarathsrinivasan76@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
SRM IRB |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M259||Joint disorder, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
CBCT IMAGING IN BRUXISM PATIENTS WITHOUT TMJ PAIN |
COMPARING THE OSSEOUS CHANGES OF CONDYLE IN BRUXISM PATIENTS WITHOUT TMJ PAIN. PATIENTS WITH BRUXISM WERE TREATED WITH OCCLUSAL SPLINT FOR 3 TO 6 MONTHS. |
Intervention |
CBCT IMAGING IN BRUXISM PATIENTS WITH TMJ PAIN |
COMPARING THE OSSEOUS CHANGES OF CONDYLE IN BRUXISM PATIENTS WITH TMJ PAIN. PATIENTS WITH BRUXISM WERE TREATED WITH OCCLUSAL SPLINT FOR 3 TO 6 MONTHS AND SYMPTOMATIC TEMPOROMANDIBULAR JOINT(TMJ) PAIN WAS MANAGED BY PAIN RELIEVERS(such as MYOSPAZ TH) FOR 1 WEEK. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
35.00 Year(s) |
Gender |
Both |
Details |
1.Age criteria between 20-35 years
2.Both male and female patients are included in the study
3.Patients with parafunctional habit of bruxism
|
|
ExclusionCriteria |
Details |
1.patients who are not willing for the study
2.patient with recent history of trauma to the jaw and TMJ.
3.patients who undergoing and underwent treatment for bruxism
4.patient who undergoing orthodontic treatment.
5.Rheumatoid arthritis
6.Juvenile idiopathic arthritis
7.patients with metal restorations and implants
8.Rad iosensitive patients and with history of heavy radiation exposure
9.Physically challenged and mentally retarded persons
10.pregnant and lactating women
|
|
Method of Generating Random Sequence
|
Stratified randomization |
Method of Concealment
|
Other |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
INCREASED OSSEOUS CHANGES OF CONDYLE IN BRUXISM PATIENTS WITH TMJ PAIN WILL RESULTS IN DEGENERATIVE CHANGES OF TMJ WHICH WILL ULTIMATELY LEADS TO OSTEOARTHRITIS OF TEMPOROMANDIBULAR JOINT(TMJ) IN YOUNG AGED PEOPLE. |
6 MONTHS |
|
Secondary Outcome
|
Outcome |
TimePoints |
OSSEOUS CHANGES OF CONDYLE IN BRUXISM PATIENTS WITHOUT TMJ PAIN MAY HAVE RISK OF DEVELOPING OSTEOARTHRITIS OF TEMPOROMANDIBULAR JOINT(TMJ),HENCE EARLY DIAGNOSIS OF OSSEOUS CHANGES OF CONDYLE IN SUCH PATIENTS WILL BE A WAKEUP CALL FOR THESE PATIENTS FOR TIMELY MANAGEMENT WILL PREVENT FURTHER PROGRESSION TO OSTEOARTHRITIS OF TMJ. |
6 MONTHS |
|
Target Sample Size
|
Total Sample Size="31" Sample Size from India="31"
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" |
Phase of Trial
|
Phase 3/ Phase 4 |
Date of First Enrollment (India)
|
15/08/2021 |
Date of Study Completion (India) |
29/01/2022 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
29/01/2022 |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Various studies are carried out for assessment of condylar bony changes in temporomandibular Disorder (TMD) using many imaging modalities like Orthopantomogram (OPG), Computed Tomography (CT) and cone beam computed tomography (CBCT) . Although TMD is a disease of multifactorial origin, some studies have shown that these conditions are associated with anxiety, depression, oral parafunctional habits like bruxism, poor socioeconomic status and genetic factors. The incidence of condylar bony changes in TMJ is more frequent with increase in age. Remodeling is a adaptive response of cartilage and osseous tissue to forces applied to the joint that may be excessive . some studies had suggested that condylar remodeling was age related. Whereas with the association of parafunctional habits like bruxism, the deterioration of osseous component of condyle will occur in younger age. This results in degenerative osseous changes like flattening, resorption, sclerosis, erosion, osteophyte and ely’s cyst. These remodeling were precursor to Temporomandibular joint Disorder(TMD). Previous studies have employed the conventional two dimensional imaging modalities like OPG, and other extraoral radiographs like reverse townes, transpharyngeal ,transorbital with advancing technology, CBCT provides a three dimensional view of TMJ in all aspects and is more reliable to assess the osseous changes. Thus our study aims to assess the correlation between bruxism and incidence of osseous changes in condyle of both symptomatic and asymptomatic TMJ patients. This can help in controlling the progression of the disease by timely management. |