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Efficacy of BoNT-A treatment in patients with Awake Bruxism and Temporomandibular Disorder (TMD)

Awake Bruxism Diagnosis and Treatment - Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-62cftbp
Enrollment
Unknown
Registered
2024-01-09
Start date
2021-03-20
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

Bruxism

Interventions

This is a controlled blind randomized clinical trial. Randomization will be performed before the procedures using an internet-based computer program (http://www.randomization.com/) in blocks of 4 pati

Sponsors

Faculdade de Odontologia da Universidade do Estado do Rio de Janeiro
Lead Sponsor
Faculdade de Odontologia da Universidade do Estado do Rio de Janeiro
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Volunteers of both genders; aged between 18 and 60 years; with Temporomandiibular Disorders; With high frequency of awake bruxism activity

Exclusion criteria

Exclusion criteria: Volunteers with facial and Temporomanbular Joint trauma; using full dentures or removable partial dentures; ongoing orthodontic treatment; blood dyscrasia patients; with presence of arthritis; arthrosis; diabetes; neurological pathologies; fibromyalgia; who received tetanus vaccine or botulinum toxin injections in the three months prior to the study

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: Frequency of Awake Bruxism activity reduction in a period of six months, verified through ecological momentary assessment (BruxApp®) and the Oral Behavior Checklist.

Secondary

MeasureTime frame
Expected outcome 2: Pain reduction in a period of six months, verified through the methods of Visual Analog Scale (VAS), from the evidence of a decrease of at least 2 points in VAS.;Expected outcome 3: Decrease in psychosocial impairment in six-month period, verified through anxiety, depression and stress questionnaires; with an evidence of a decrease of at least 5% in pre and post-intervention measurements.

Countries

Brazil

Contacts

Public ContactTatiana Foscaldo

Faculdade de Odontologia da Universidade do Estado do Rio de Janeiro

tatifoscaldo@gmail.com+55(21)2868-8287

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 2, 2026