Evidence map›Paper›PMID 41219710›Full record

Trial reportBMC oral health2025

Comparing botulinum toxin and biofeedback therapies for awake bruxism: a randomized clinical trial.

Tatiana Ferreira Foscaldo, Paulo Henrique Dos Santos Belo Junior, Giselle Rodrigues Ribeiro, Leilane Samary de Proença, Giancarlo De la Torre Canales, Plinio Mendes Senna

Abstract readRandomized Controlled TrialComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC oral health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Tatiana Ferreira FoscaldoDepartment of Prosthodontics, Rio de Janeiro State University, Rio de Janeiro, Rio de Janeiro, Brazil.
Paulo Henrique Dos Santos Belo JuniorDepartment of Prosthodontics, Rio de Janeiro State University, Rio de Janeiro, Rio de Janeiro, Brazil.
Giselle Rodrigues RibeiroDepartment of Prosthodontics, Rio de Janeiro State University, Rio de Janeiro, Rio de Janeiro, Brazil.
Leilane Samary de ProençaDepartment of Stomatology, Piracicaba Dental School, University of Campinas (UNICAMP), Piracicaba, São Paulo, Brazil.
Giancarlo De la Torre CanalesEgas Moniz Center for Interdisciplinary Research (CiiEM), Egas Moniz School of Health & Science, Caparica, Almada, Portugal. giancarlo.de.la.torre.canales@ki.se.
Plinio Mendes SennaDepartment of Prosthodontics, Rio de Janeiro State University, Rio de Janeiro, Rio de Janeiro, Brazil.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBehavioral therapy using electromyography-based biofeedback (BIO) and botulinum toxin type A (BTA) injections are potential treatments for managing awake bruxism (AB) in patients with temporomandibular disorders (TMD). The aim of this study was to compare the effectiveness of BIO and BTA in reducing AB behaviors, pain intensity, and psychosocial distress in individuals with TMD.

methodsThis single-center, single-blind, parallel-group randomized clinical trial enrolled 40 adults with TMD diagnosed with AB. AB was assessed using the Oral Behavior Checklist (OBC) and smartphone-based Ecological Momentary Assessment (EMA). Participants presenting an AB frequency of ≥ 60% were randomly allocated to receive BIO or BTA intervention. Pain intensity was measured by the Characteristic Pain Intensity (CPI) score, and psychosocial status was evaluated using the Patient Health Questionnaires (PHQ-9, PHQ-15) and the Generalized Anxiety Disorder questionnaire (GAD-7). Assessments were conducted at baseline, and at 1-, 3-, and 6-month follow-ups. Statistical analyses included Mann-Whitney U for AB behaviors, Wilcoxon Signed Rank test for within-group comparisons, and the Kruskal-Wallis test followed by the Dwass-Steel-Critchlow-Fligner post hoc test for between-group comparisons.

resultsIntra-group comparisons showed a significant reduction in BIO group for sustained teeth contact (BIO: p = 0.004) and EMA-assessed AB global behavior (BIO: p = 0.008). No significant improvements were found in BTA group for the same variables in all follow-ups (p > 0.05). However, no significant differences were found between groups in all follow-ups for OBC and EMA scores (p > 0.05). Similarly, there were no significant differences between groups for CPI (p = 0.39) or psychosocial outcomes (p > 0.05).

conclusionEven though neither intervention improved pain nor psychosocial outcomes, BIO significantly reduced AB behaviors, indicating that BIO may be preferable for controlling AB behaviors in TMD patients.

trial registrationBrazilian Registry of Clinical Trials (ReBEC), RBR-62cftbp. Registered on January 9, 2024.

Indexed as

Biofeedback, PsychologyBotulinum Toxins, Type ABruxismNeuromuscular AgentsTemporomandibular Joint DisordersAdultElectromyographyFemaleHumansMaleMiddle AgedPain MeasurementSingle-Blind MethodTreatment OutcomeYoung AdultBotulinum Toxins, Type ANeuromuscular AgentsBruxismEcological momentary assessmentElectromyographyMyofascial painPsychological biofeedbackTemporomandibular disorders

Identifiers

PMID41219710
PMCPMC12607165

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.