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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

Developing indigenous patient specific alloplastic total temporomandibular joint replacement system and its evaluation on mandibular kinematics, quality of life and survivability of implant in patients requiring temporomandibular joint replacement.- Prospective Observational Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/11/029339
Enrollment
25
Registered
2020-11-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M278- Other specified diseases of jaws

Interventions

Intervention1: Indigenous patient specific alloplastic total temporomandibular joint replacement: A new Indigenous patient specific alloplastic jaw joint will be designed and used in patients with TMJ

Sponsors

Ministry of Health and Family welfareGovernment of India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients requiring alloplastic total TMJ replacement Patients giving consent for the procedure

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Maximum Interincisal Opening (MIO)Timepoint: pre operative,1 month,3 months,6 months,1 year,2 year and 3 year post operative—

Secondary

MeasureTime frame
Left 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—

Countries

India

Contacts

Public ContactAjoy Roychoudhury

All India Institute of Medical Sciences,New Delhi

ajoyroy@hotmail.com9891007749

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026