Innovative jaw reconstruction system in jaw-joint disorders.

Development and design of novel prosthetic total temporomandibular joint (TMJ) reconstruction system in patients with temporomandibular joint disorder - NIL

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/077090

Enrollment

Registered

2024-11-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

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: NOVEL PROSTHETIC TOTAL TEMPOROMANDIBULAR JOINT (TMJ) RECONSTRUCTION SYSTEM: All of the patients would be fully informed of the nature of their problem and the fact that the surgical tre

Eligibility

Inclusion criteria

Inclusion criteria: a) End-Stage Temporomandibular disorders including Internal disc derangement and osteoarthritis b) Late-stage degenerative joint disease (osteoarthritis, rheumatoid arthritis, traumatic arthritis, etc.) c) Ankylosis irrespective of site and duration of ankylosis d) Revision procedures for failed alloplastic or autogenous reconstruction f) Neoplasia/cyst requiring resection of TMJ

Exclusion criteria

Exclusion criteria: a) Allergy to any of the prosthetic materials b) Systemic disease with increased susceptibility to infection c) Known neurologic/psychiatric disorders, d) Uncontrolled systemic disorder or immunocompromised state, e) Patient not willing to participate in study f) Skeletally immature patients g) Bilateral ankylosis cases / bilateral temporomandibular joint disorders

Design outcomes

Primary

Measure	Time frame
A.Subjective Outcomes 1)Improvement in pain levels 2. Improvement in diet and jaw function B.Objective Outcomes 1.Changes in range of motion of mandible 2.Changes in Occlusion 3.Changes in Mandibular deviation 4.Electromyography 5.Bite force 6.Total Time of surgical procedure 7.Facial nerve function 8.Other complications of surgical procedure C.Quality of life D. Changes in Joint morphology Timepoint: The outcomes will be assessed/estimated Preoperatively(baseline), at 1-month, 3-months and 6-months follow-up	—

Measure

Time frame

A.Subjective Outcomes 1)Improvement in pain levels 2. Improvement in diet and jaw function B.Objective Outcomes 1.Changes in range of motion of mandible 2.Changes in Occlusion 3.Changes in Mandibular deviation 4.Electromyography 5.Bite force 6.Total Time of surgical procedure 7.Facial nerve function 8.Other complications of surgical procedure C.Quality of life D. Changes in Joint morphology Timepoint: The outcomes will be assessed/estimated Preoperatively(baseline), at 1-month, 3-months and 6-months follow-up

—

Secondary

Measure	Time frame
Develop and design a novel total temporomandibular joint (TMJ) reconstruction system in a cohort of patients treated for Temporomandibular joint disorders (TMJ) suitable for Indian population.Timepoint: 3 years	—

Countries

India

Contacts

Public ContactAnjali Verma

Maulana Azad Institute of Dental Sciences

anjalidevchugh@gmail.com8447801126

Outcome results

None listed

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