Skip to content

Botox study and facial Anesthetic Infiltration on the Tinnitus Intensity in Patients with Temporomandibular Disorders

Clinical trial of botulinum toxin and facial anesthetic infiltration in tinnitus intensity in patients with temporomandibular disorder

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-73jdz5
Enrollment
Unknown
Registered
2020-06-02
Start date
2018-01-02
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 Disorders, Otoneurological Diseases, Quality of Life, Bruxism

Interventions

3 groups will be formed, where each will be composed of 33 patients
group A: botulinum toxin type A will be applied
group B: 2% lidocaine without vasoconstrictor
and group C (placebo): 0.9% saline solution. Both doctors and patients will be blind as to the substance to be applied. After this stage, the first application of botulinum toxin, lidocaine or saline
Drug
HP3.073.433.101

Sponsors

Hospital Universitário Professor Edgard Santos/UFBA
Lead Sponsor
Hospital Universitário Professor Edgard Santos/UFBA
Collaborator

Eligibility

Age
15 Years to 100 Years

Inclusion criteria

Inclusion criteria: Temporomandibular joint disorder diagnosis; otoneurologic symptoms for at least three months; at least 15 years of age; both genders; no current treatment for temporomandibular disorder or otoneurologic disease.

Exclusion criteria

Exclusion criteria: Allergy to lidocaine or botulinum toxin; anyone who changed therapies during the study to avoid false-positive; imunossupressed patients; diabetes mellitus; cognitive impairment; pregnancy or breast feeding; psychiatric disorders; skin conditions; clotting disturbances; neuromuscular diseases; using clacium channel blokers; antibiotics (aminoglycosides); cyclosporin; chloroquines; hydroxichloroquine; D-penicillamine; or anu=y other substance that interferes with neuromuscular transmission; Myasthenia gravis; Eaton Lambert syndrome; Amyotrophic sclerosis; or any disturbances that promote periferal neuromuscular dysfunction; oral anticoagulante; derivates from acetylsalicylic acid; derivates from vitemin E ou Ginko Biloba

Design outcomes

Primary

MeasureTime frame
The primary outcome was a reduction of at least 30% in the intensity of tinnitus determined through a questionnaire, at any intensity when compared to the initial condition, to verify whether the outcome actually happened.

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactIza Cristina de Castro

Hospital Universitário Professor Edgard Santos/UFBA

dra.cristinasalles@gmail.com5507121092210

Outcome results

None listed

Source: REBEC (via WHO ICTRP)