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
|
|
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
|
|
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 |