Temporomandibular joint disorders
Conditions
Interventions
Patients with consolidated bone conformation, in advanced stages of pathologies associated with the temporomandibular joint, where traditional and conservative approaches have already been used and ha
E04.545.510
E06.892
Sponsors
Complexo de Saúde São João de Deus
Complexo de Saúde São João de Deus
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients 18 years or older presenting consolidated bone conformation; in advanced stages of temporomandibular joint disorders; in which traditional and conservative approaches have already been tried and have failed; such as osteoarthritis; tumors; trauma; inflammatory or degenerative pathologies of the temporomandibular joint (TMJ); autoimmune tissue connective diseases affecting the TMJ; fibrous or bone ankylosis; missing or deformed structures and spondyloarthropathies.
Exclusion criteria
Exclusion criteria: Patients in constant use of analgesics or anti-inflammatory drugs; syndromic; immunosuppressed; diabetic patients with uncontrolled coagulopathies; and hypertensive patients. Participants will also be excluded from the study if they have other treatment alternatives; have uncontrollable masticatory muscle hyperfunction such as bruxism; or known allergy to prothesis' material; Participants previously implanted with ATM prostheses will also be excluded from the study; as well as participants who need reconstruction that is not restricted to the branch and that encompasses the mandibular body.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Expected outcome 1 - Evaluation of efficacy and safety of total replacement of the temporomandibular joint by the patient-specific prosthesis by measuring the incisal opening and maximum lateral excursion found, verified before the surgical procedure, in the immediate postoperative period, after 7 days, 30 days, 6 months, 12 months and 18 months. With the aid of a caliper, the distance between the lower and upper incisal edges will be measured. In addition, the Therabite system will also be used to measure the maximum incisal opening and lateral excursion. The values will be noted and later compared with their values in previous times, in order to assess improvement or worsening in the measured indicators. Significant variation is expected after the installation of the patient-specific system, but this will be assessed individually.;Primary Expected outcome 2 - Evaluate occlusal stability by means of cephalometric analysis and by recording the immediate postoperative clinical occlusal relationship with long-term results in relation to the Angle classification. Angle's classification predicts three classifications based on the relationship between the first molars of both arches as a key factor. A significant improvement in occlusal stability is expected, which will be individually assessed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome 1 - Subjective pain assessment using a Visual Analogue Scale, where patients will be instructed to measure the level of pain in the first 24h, 48h, 72h and 7 days using a Visual Analogue Scale, where: 0 = No pain and 10 = Excessive Pain. None of the patients is expected to have a grade equal to or greater than 5.;Secondary outcome 2 - Subjective evaluation of the function of the jaws, where evaluated participants should assess their ability to chew and perform jaw movements, as well as taking into account their discomfort. They will be instructed to note on the Visual Analogue Scale their evaluation of functionality after the installation of the prosthesis, where: 0 = Normal function 10 = Dysfunctional. None of the patients is expected to have a level greater than or equal to 5. | — |
Countries
Brazil
Contacts
Public ContactCPMH
Outcome results
None listed