Behavioral Interventions for Controlling Oral Behaviors

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Toronto

About this trial

Ecological momentary assessment (EMA) interventions via mobile devices can be implemented to monitor an individual's negative health behaviors in real-time, increase awareness, and assist patients in overting those behaviors. In recent years, EMA interventions have been used to improve patients' awareness of specific oral behaviors, such as tooth clenching or awake bruxism, which can produce excessive forces on the muscles of mastication and lead to or exacerbate symptoms of temporomandibular disorders (TMD). Yet, whether EMA interventions are effective in reducing oral behaviors and masticatory muscle activity in the short- and long-term, or whether they are more effective than patient education remains unclear.

In this randomized clinical trial, we aim to test the effects of a 1-week EMA intervention combined with structured information on masticatory muscle activity and determine whether a combined approach including an EMA intervention and structured information is more effective in reducing masticatory muscle activity than structured information alone.

Our study will have a significant impact on orofacial pain clinical research as it will provide clinically relevant measures which could inform multimodal approaches for the management of painful TMD.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Educational video combined with daily surveys

    Behavioral

    Participants will receive the same educational intervention as those in the other arm and will also undergo an ecological momentary assessment (EMA) intervention. This will involve receiving multiple messages per day on their mobile phones, each linking to an online survey designed to capture real-time data on their current oral behaviors. The intervention aims to increase participants' awareness of these behaviors by prompting them to reflect on and report them throughout the day.

  • Educational video only

    Behavioral

    Participants will be provided with an educational video on recognizing and managing oral behaviors such as clenching, prolonged tooth contact, and keeping the jaw tense, etc. The goal is to increase awareness and promote behavior change to reduce strain to the masticatory muscles and the temporomandibular joint.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Standard of careActive comparator 1 intervention
Group B: Standard of care combined with an ecological momentary assessment interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of oral behaviors

Frequency of electromyographic (EMG) activity periods greater than 5 and 10% of participants' maximum voluntary contraction, measured using ambulatory EMG.

Time frame
after one week intervention

Secondary outcomes

1

Duration of oral behaviors

Duration of electromyographic (EMG) activity periods greater than 5 and 10% of participants' maximum voluntary contraction, measured using ambulatory EMG

Time frame
after one week intervention

Other outcomes

Sponsors and contacts

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