Developing indian made artificial jaw joint system and its evaluation on jaw functions like mouth opening, quality of life and survivability of the artificial joint in patients requiring jaw joint replacement
Not Applicable
- Conditions
- Health Condition 1: M278- Other specified diseases of jaws
- Registration Number
- CTRI/2020/11/029339
- Lead Sponsor
- Ministry of Health and Family welfareGovernment of India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients requiring alloplastic total TMJ replacement
Patients giving consent for the procedure
Exclusion Criteria
Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
Pregnancy or women planning to conceive within the study period
Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum Interincisal Opening (MIO)Timepoint: pre operative,1 month,3 months,6 months,1 year,2 year and 3 year post operative
- Secondary Outcome Measures
Name Time Method eft lateral excursion of mandible in mmTimepoint: pre operative,1 month,3 months,6 months,1 year,2 year and 3 year post operative;Quality of life questionnaireTimepoint: pre operative,1 month,3 months,6 months,1 year,2 year and 3 year post operative;Right lateral excursion of mandibleTimepoint: pre operative,1 month,3 months,6 months,1 year,2 year and 3 year post operative