Efficacy of botulinum toxin type A in myogenic temporomandibulardisorders: a single arm, prospective, pilot study.

There was no control or placebo group, so the study cannot separate the injection effect from placebo effect. This was a pilot with 25 participants and no formal sample size calculation, so it is preliminary. Follow-up was only 12 weeks, and treatment was a single injection, so longer-term effects and repeat-dosing effects are unknown. Participants were recruited from two academic clinics, so results may not apply to typical community temporomandibular disorder care. The examiner was not blinded to the assessment timepoint, and the outcomes were based on patient-reported symptoms. Psychosocial Axis II measures were not collected, although anxiety, depression and stress are part of the condition's biopsychosocial background. The study did not compare botulinum toxin with other treatments, so relative benefit is unknown. The study did not measure mandibular bone or muscle structural outcomes, so long-term structural safety is not shown. The report does not give a separate number who completed all assessments; missing data were less than 5% and handled by listwise deletion.

The authors declared that no financial support was received for the work or its publication.

Do not conclude that botulinum toxin type A is proven effective for myofascial temporomandibular disorder. This was a single-arm pilot with no placebo control, so the reported improvements cannot be separated from placebo effects.