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CTRI Number  CTRI/2020/12/029529 [Registered on: 03/12/2020] Trial Registered Prospectively
Last Modified On: 25/11/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   The dislocation of Jaw Joint is assessed using special CT.  
Scientific Title of Study   The evaluation of imaging modality to determine the ideal treatment modalities in patients with TMJ Dislocation- A prospective clinical study 
Trial Acronym  CBCT- TMJD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  LOGITHA SRI S 
Designation  PG Student 
Affiliation  SRM DENTAL COLLEGE 
Address  Department of Oral and Maxillofacial Surgery, SRM dental College, Ramapuram, Chennai- 600089.
Department of Oral and Maxillofacial Surgery, SRM dental College, Ramapuram, Chennai- 600089.
Chennai
TAMIL NADU
600089
India 
Phone  9148379219  
Fax    
Email  drlogithasri.s@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  SASIKALA B 
Designation  READER 
Affiliation  SRM DENTAL COLLEGE 
Address  Department of Oral and Maxillofacial Surgery, SRM Dental College, Ramapuam, Chennai - 600089.
Department of Oral and Maxillofacial Surgery, SRM Dental College, Ramapuam, Chennai - 600089.
Chennai
TAMIL NADU
600089
India 
Phone  9148379219  
Fax    
Email  sasiomfs@gmail.com  
 
Details of Contact Person
Public Query
 
Name  LOGITHA SRI S 
Designation  PG Student 
Affiliation  SRM DENTAL COLLEGE 
Address  Department of Oral and Maxillofacial Surgery, SRM Dental College, Ramapuam, Chennai - 600089.
Department of Oral and Maxillofacial Surgery, SRM Dental College, Ramapuram, Chennai - 600089.
Chennai
TAMIL NADU
600089
India 
Phone  9148379219  
Fax    
Email  drlogithasri.s@gmail.com  
 
Source of Monetary or Material Support  
Bharathi Salai, SRM DENTAL COLLEGE, Ramapuram, Chennai- 600089. 
 
Primary Sponsor  
Name  LOGITHA SRI S 
Address  Department of Oral and Maxillofacial Surgery, SRM Dental College, Ramapuam, 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 
Dr LOGITHA SRI S  SRM DENTAL COLLEGE  Ground floor, Department of OMFS, SRM DENTAL COLLEGE, RAMAPURAM, CHENNAI - 600089.
Chennai
TAMIL NADU 
9148379219

drlogithasri.s@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (2) ICD-10 Condition: M244||Recurrent dislocation of joint,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1) Patients with TMJ Dislocation into study group and normal into control group
2) No previous TMJ surgeries
 
 
ExclusionCriteria 
Details  1) Patient with previous history of TMJ surgery
2) Patient with age <18 and >50
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
condylar head height,
condylar head width,
articular eminence height, articular eminence inclinaion 
At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
condylar head height,
condylar head width,
articular eminence height, articular eminence inclinaion 
baseline 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 1 
Date of First Enrollment (India)   04/12/2020 
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 Applicable 
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  

Subluxation or dislocation of the temporomandibular joint (TMJ) is an acutely painful condition in which the condyle glides out of the glenoid fossa with  inability to descend back to normal position. The incidence of dislocation is 7% .  It occurs due to imbalance in the neuromuscular function, structural variation in eminence, fossa, or condyle and laxity of the ligaments &capsule. Dislocation is precipitated spontaneously or by trauma,aging and changes in the dentition, wide mouth opening, certain antipsychotic medications, and some syndromes. Dislocation is commonly mismanaged because of improper localization of pathology. The treatment for TMJ Dislocation is generally done based on creating or removing the obstacle in condylar movement. Here, in this study we are going to measure the osseous anatomy of  TMJ components to determine the discrepancy using Cone Beam Computed Tomography (CBCT).  The CBCT allows measurement of  TMJ bony structures with high accuracy. Also proposing new Diagnostic Algorithm to choose the Ideal treatment option for the respective discrepancy.

RESEARCH AIM:

          This study was therefore designed to analyze the discrepancy in the osseous component of the TMJ and to propose a diagnostic algorithm to choose the ideal treatment protocol.

 

 

MATERIALS AND METHODS:

o   SAMPLE SELECTION: 50 patients with age of 18 to 50 were recruited into the study and  allotted into two groups.

CONTROL GROUP:(n=25)Patients with no history of subluxation.

STUDY GROUP:(n=25)Patients with history of subluxation.

o   Clinical evaluation included assessment of mouth opening, clicking and pain.

o   Radiologic evaluation using CBCT.

o   PARAMETERS: CBCT evaluation included measurement of

                             -width and height of condylar head.

                             -width, height and inclination of articular eminence.

RESULTS/FINDINGS:

          To compare mean and standard deviation of parameters between study and control groups independent samples unpaired t-test was applied. For variables which did NOT follow Normal distribution, to compare between study and control groups wilcoxon test was used.

CONCLUSION:

          Relative ratio of the depth of glenoid fossa to height of articular eminence which can predispose to dislocation was determined. This was called the critical ratio. Patients with lower critical ratio required osseous surgery while patients with higher ratio required soft tissue surgery.

 
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