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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  
SRM DENTAL COLLEGE  
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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