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Treatment of pain and damage of the Joint of the Mandible by means of Injection of Hialuronato de Sódio Medicine

Evaluation of the Efficacy of Sodium Hyaluronate Injection in the treatment of signs and symptoms of Temporomandibular Joint Dysfunctions

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-6759yz
Enrollment
Unknown
Registered
2018-02-23
Start date
2016-02-02
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Temporomandibular joint disorder syndrome

Interventions

Viscosupplementation is performed with the injection of sodium hyaluronate without upper joint compartment, accessed through the rebreathing of a point in the preauricular region approximately 1 cm in
Drug

Sponsors

Universidade Federal de Minas Gerais
Lead Sponsor
Universidade Federal de Minas Gerais
Collaborator
Universidade Federal do Rio de Janeiro
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Individuals from 18 to 70 years; of both sexes; with clinical and imaging diagnosis of disc displacement of the temporomandibular joint with or without reduction

Exclusion criteria

Exclusion criteria: Patients with rheumatologic diseases, neuropathic pain or history of previous TMJ surgery, trauma or fractures; Patients previously submitted to therapy by viscossuplementation, arthroscopy or arthrocentesis.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: Decreased pain intensity; Through a numerical visual scale, applied before and after the cycle of interventions, the intensity of pain experienced in the TMJ submitted to digital palpation of 0.5 kg was measured at the moments examined; The values assigned ranged from 0 to 10, where 0 = no pain and 10 = worst pain experienced; The comparison of the final values with respect to the baseline was performed individually in each case evaluated. Final values smaller than the initial values were considered as satisfactory, while final values = 0 indicated total therapeutic efficacy in the short term. A minimum of 1 unit on the numerical scale was expected at the end of cycles. The statistical value of p <0.05 was considered significant. ;Outcome found 1: the individuals had a decrease in pain intensity at the end of the interventions in relation to the initial intensity. The initial mean was 7.3 while the final 2.2. Five subjects had final pain intensity = 0 (p<0,05).;Outcome 2: Optimization of clinical joint dysfunction; It was evaluated by the degree of mandibular movement from the measurement in millimeters of the maximum buccal opening, maximum lateral movement to the right and to the left, in addition to the maximum protusive movement, measured with precision digital caliper, taking as reference the region between upper central incisors and lower and possible midline deviations; A final oral opening measured at 40-45 mm was considered normal, while lateral and protrusive opening values were considered normal when the 1/4 measure of the mouth opening was reached. The gain in mouth opening amplitude was also verified by the positive difference between the measurements of the end of the viscossuplementation cycle in relation to the baseline. It was expected that the amplitude of the buccal opening and excursive movements due to viscosupplementation were increased in cases where mobility was initially reduced. The statistical value of p <0.05 was consi

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactLuciano Ferreira

Universidade Federal de Juiz de Fora

l3a6f9@yahoo.com.br+55(32)3224-5637

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 21, 2026