Recruiting

EMA Intervention

Sponsor:

University of Toronto

Code:

NCT07022795

Conditions

Temporomandibular Disorders (TMD)

Bruxism

Masseter

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Educational video combined with daily surveys

Educational video only

Study Details

Brief summary:

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.

Conditions

Temporomandibular Disorders (TMD)

Bruxism

Masseter

Study ID

NCT07022795

Start date

Apr 15, 2025

Status verified date

Jun, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Individuals reporting a score greater than or equal to 25 on the oral behavior checklist (OBC). The OBC is a self-report questionnaire used to assess the frequency of various daytime and sleep-related oral behaviors, such as teeth clenching, grinding, and jaw tension.

It helps identify habits that may contribute to temporomandibular disorders (TMD) and orofacial pain.

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Standard of care

Group A

experimental: Standard of care combined with an ecological momentary assessment intervention

Group B

Interventions

Educational video combined with daily surveys

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

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.

Primary outcome measure

  • Frequency of oral behaviors [ Time Frame: after one week intervention ]

Central Contacts and Locations

Central contacts

Iacopo Cioffi Associate Professor, Principal investigator, DDS, PhD

+14168648107iacopo.cioffi@dentistry.utoronto.ca

Locations

Faculty of Dentistry

Recruiting

Toronto, Ontario, Canada, M5G1G6

Contacts

More Information

Sponsor

University of Toronto

Last update posted

Jun 15, 2025

Last verified

Jun, 2025

Keywords

  • awake bruxism
  • temporomandibular disorders
  • masseter
  • oral behaviors
  • surface electromyography
  • tooth clenching

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2025-06-15.