CompletedPhase 2ACTRN12618001430224

Botulinum toxin for nocturnal bruxism.

Efficacy of Botulinum Toxin Type A in the Targeted Treatment of Nocturnal Bruxism: A Double-Blind, Randomised, Placebo-Controlled Cross-over Study

Sponsor

Melbourne Health

Enrollment

30 participants

Start Date

Feb 5, 2016

Study Type

Interventional

Conditions

Bruxism

Summary

Bruxism is a diurnal or nocturnal involuntary repetitive oral activity consisting of a non-functional rhythmic (or spasmodic) grinding, clenching or gnashing movement of the teeth. The diagnosis of bruxism is made by reports of tooth grinding/clenching during sleep, and one of either: abnormal tooth wear, sounds associated with bruxism, and/or jaw muscle discomfort. In adults, the prevalence of sleep bruxism is reported to be around 6% for the grinding type and 20% for the clenching type. Sleep bruxism has been linked to a variety of headache syndromes including temporomandibular disorders and chronic migraine. The ultimate goal of this research is to develop a more effective therapeutic intervention for bruxism sufferers with the use of BTA injection. Patients will mainly be recruited via the Botulinum Toxin Clinic at Royal Melbourne Hospital, as well as via referrals from dental orofacial pain specialists and neurologists. The study is a randomized, double blind, placebo-controlled trial with a crossover design; the study duration is 40weeks from the time of randomisation. All participants meeting eligibility criteria will be required to consent to approved study protocols.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

Symptoms of nocturnal bruxism of adequate severity as measured by overnight monitoring.

Exclusion Criteria1

Contraindication to botulinum toxin administration, concurrent use of medications affecting muscle relaxation, prior history of severe jaw trauma, orofacial pain of an alternate aetiology, neuromuscular disease, major respiratory disease(s) that may preclude overnight EMG recordings, administration of botulinum toxin for other indication (including cosmetic) within 16weeks of study commencement.

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Interventions

The intervention is a set of injections at 2 time points, at least 20 weeks apart, performed by a trained neurologist at Royal Melbourne Hospital. The treatment consists of intramuscular injections of Botox (onabotulinumtoxinA) (dose range of 90-120units as detailed below) and 0.9% normal saline (dose range 1.8ml-2.4ml), in a randomised, double blind, cross-over study. The doses detailed are based on the minimally clinically effective doses within the range of those used in published studies. Patients will be randomised to receive injections into: A. Masseter muscles bilaterally (30 units or 0.6ml normal saline each side); B. Masseter and temporalis muscles bilaterally (30 units/15 units each muscle respectively, or 0.6ml/0.3ml respectively); or C. Masseter, temporalis and medial pterygoid muscles bilaterally (30units/15units/15 units each muscle respectively, or 0.6ml/0.3ml/0.3ml normal saline respectively). The duration of treatment effect for botulinum toxin injected into the face, head and neck area has been observed to be approximately 3-4 months. Therefore a 20-week (5month) washout period was chosen to ensure that there is no remaining active treatment effect before the cross-over set of injections. At 20 weeks, there will therefore be a single set of injections, of either active treatment or placebo, in the same sites as the first injection, again performed by a trained Neurologist at Royal Melbourne Hospital. Study investigators will contact the participants to arrange followup within 7 days of the specified timepoint, for clinical assessment and outcome measures. Participants will also be given dates for followup in advance of the scheduled timepoints to ensure fidelity to the intervention followup schedule.