Behavioral Interventions for Controlling Oral Behaviors

NCT07022795 | Recruiting

• 1 other identifier: 46622
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

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.

  after one week intervention

Secondary Outcomes (1)

• Duration of oral behaviors

  after one week intervention

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Group A

Behavioral: Educational video only

Standard of care combined with an ecological momentary assessment intervention

EXPERIMENTAL

Group B

Behavioral: Educational video combined with daily surveys

Interventions

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.

Standard of care combined with an ecological momentary assessment intervention

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.

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Faculty of Dentistry

Toronto, Ontario, M5G1G6, Canada

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Bruxism

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Tooth Diseases; Habits; Behavior

Central Study Contacts

Iacopo Cioffi Associate Professor, Principal investigator, DDS, PhD

CONTACT

+14168648107; iacopo.cioffi@dentistry.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The operator performing the data analysis will be blinded to the research dataset through dataset masking
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 7, 2025
• First Posted: June 15, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)