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CTRI Number  CTRI/2019/01/017023 [Registered on: 09/01/2019] Trial Registered Prospectively
Last Modified On: 09/01/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A study used to observe function of jaw joint in the patients who underwent dental treatment procedures using a machine called joint vibratory analysis. 
Scientific Title of Study   Analysis of dynamic function of Temporomandibular joint in subjects before and after dental treatment procedures using joint vibratory analysis- A cross sectional observational study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nallakunta Rajesh 
Designation  Assistant Professor 
Affiliation  Vishnu Dental College 
Address  Vishnu Dental College Vishnupur Department of Oral Medicine and Radiology

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9885067499  
Fax    
Email  rajeshcap09@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nallakunta Rajesh 
Designation  Assistant Professor 
Affiliation  Vishnu Dental College 
Address  Vishnu Dental College Vishnupur Department of Oral Medicine and Radiology

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9885067499  
Fax    
Email  rajeshcap09@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nallakunta Rajesh 
Designation  Assistant Professor 
Affiliation  Vishnu Dental College 
Address  Vishnu Dental College Vishnupur Department of Oral Medicine and Radiology

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9885067499  
Fax    
Email  rajeshcap09@gmail.com  
 
Source of Monetary or Material Support  
Dr.Nallakunta Rajesh Assistant professor Vishnu Dental college Vishnupur Bhimavaram 
 
Primary Sponsor  
Name  DrNallakunta Rajesh 
Address  Dr Nallakunta Rajesh Department of Oral Medicine and Radiology Vishnu dental college Vishnupur, Bhimavaram 534202 
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 N Rajesh  Vishnu Dental College  Room number-1 Department of Oral Medicine and Radiology Vishnu dental college Vishnupur, Bhimavaram-534202
West Godavari
ANDHRA PRADESH 
9885067499

rajeshcap09@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 
Healthy Human Volunteers  healthy individuals seeking dental treatment procedures 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All the subjects seeking prosthetic partial denture and complete denture treatment.
All the subjects seeking prosthetic fixed partial denture treatment on either upper or lower arches and right and left sides
All the subjects seeking orthodontic treatment
Normal dentate subjects 
 
ExclusionCriteria 
Details  In normal dentate subjects third molars  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Positive results can be achieved with this study, as JVA provides dynamic information about the joint with the following informative data
1.Identifies a patient’s joint problems before symptoms are present
2.Proactively guide the dentist in treatment planning
3.Allows the patient to be educated and understand the health of his or her TM joints
 
3 MONTHS
6 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
1.Objectively records all the vibrations of underlying tissue during function
2.Distinguishes which side of the TMJ vibrations originate
3.Testing treatment impact instantly

With JVA, most accurate and complete diagnosis can be possible and this will help the clinician to develop an effective treatment plan 
3 years 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   10/01/2019 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

A cross-sectional observational study will be carried out among subjects attending Vishnu Dental College seeking various treatments as mentioned elsewhere after obtaining approval from institutional research and ethical committee. Patients will be explained about the need for study in local vernacular language and informed consent will be obtained from each subject. A specially designed proforma will be used for data collection pertaining to general information, medical history and clinical examination. Follow up check ups with JVA will be performed for prosthetic subjects at intervals of 3 and 6 months.

 Without a clear objective and detailed assessment of TMJ function, we cannot predict the future success or failure of our dental treatments, nor can we determine if subsequent TMJ pathologies previously existed or were the result of our dental work. According to Jensen&Ruff studies, almost every third subject with sub-clinical TMD developed clinical TMD over a 2.4year period. Mc Neil states that approximately 75% of the population may experience one of the many signs of masticatory dysfunction;they emphasize that it would be deliberate to carry out systematic TMJ function analysis in all adult patients prior to the dental treatments.

The premise of this research is that a more technically accurate instrument followed by a sophisticated computer analysis might provide more accurate information by assessing the phenomenon of TMJ sounds. It has been postulated that different disorders can produce different vibration patterns or signatures in joint including TMJ. Vibration analysis of TMJ is thus a quantitative process that measures the absolute intensity and frequency distribution of vibratory waves emanating from the joint during jaw motion.The assessment of vibrations using JVA will have the potential to provide data that could be used to assess the phenomenon and indicate the status of the joint.

Understanding of different types of joint vibrations, characterized by analyzing total integral vibrations, peak frequency and mouth opening etc., are important for prevention and treatment and even follow-up of the joint pathologies. JVA is an accurate and reproducible means to record and maintain all the above characteristics permanently for each subject. JVA provides a fast, non-invasive and repeatable measurements of TMJ function to aid in the diagnosis. Understanding TMJ function is vital anytime if we are changing the vertical, lateral or antero-posterior position of the mandible as in orthodontic or prosthetic treatments.

For the above reasons, the present study will be conducted to assess these changes using JVA, that will help to better allocate with resources and address the welfare and needs of patients who undergo the concerned dental procedures

 
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