Temporomandibular Disorders (TMD)NCT07022795
Behavioral Interventions for Controlling Oral Behaviors
A study testing Educational video combined with daily surveys and Educational video only in people with Temporomandibular Disorders (TMD) and Bruxism, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorders (TMD), Bruxism, Masseter
- What is being tested?
- Educational video combined with daily surveys and Educational video only
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 15 Apr 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iacopo Cioffi Associate Professor, Principal investigator, DDS, PhD contact
Canada1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Toronto, Ontario, M5G1G6
Iacopo Cioffi, DDS, PhD, +1-416-864-8107, iacopo.cioffi@dentistry.utoronto.ca
About this study
Official title: Effectiveness of an Ecological Momentary Assessment Intervention to Reduce Masticatory Muscle Activity in Individuals at Risk for Temporomandibular Disorders
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.
Read the detailed description
Temporomandibular disorders (TMD) are the most common cause of nondental orofacial pain (1) and the second most frequent painful musculoskeletal (MSK) disorder after chronic low back pain (2). TMD affect 1/6 Canadians, mostly women (3). Painful TMD can affect the muscles of mastication and/or the temporomandibular joints (TMJs, i.e., the jaw joints), and are characterized primarily by spontaneous pain, or pain associated with jaw function, and TMJ sounds (e.g., clicking) (4). TMD pain affecting the muscles of mastication (TMD myalgia; mTMD) is the most common TMD (5). MTD mostly affect the two major muscles of mastication, i.e. the masseter and the temporalis. As in other painful MSK conditions, TMD cause considerable personal suffering, and pose a significant economic burden (6). In the USA ~$4 billion are spent annually, with >17.8 million lost work days/year for every 100 million working adults (7). Notably, ~85% of the cost of treating TMD is associated with clinical management of chronic mTMD. Despite the high prevalence of TMD, more than 30% of patients report pain for at least 5 years after treatment, regardless the treatment they had received (8) which suggests that treatments for TMD are ineffective. Consensus has been achieved in that conservative management strategies should be preferred over more invasive treatment approaches, such as prolonged pharmacological treatments or opioid use, which result in significant adverse effects that impact significantly on the quality of life of patients (9). Of importance, both laboratory and epidemiological studies indicated that oral behaviors - for example, awake bruxism, a stress-coping behavior characterized by repetitive or sustained tooth clenching(10)- might harm the muscles of mastication or the jaw joint (the temporomandibular joint, TMJ) by way of producing excessive forces to which these structures are exposed, potentially leading to, or exacerbating symptoms of TMD (11). Therefore, patient education focused on reducing the frequency of oral behaviors or awake bruxism has proven to be an effective first-line approach towards mTMD management (12-13). Notably, highly frequent oral behaviors and awake bruxism also can increase the risk of prosthetic failure (e.g., damage to restorations or crowns/bridges (14), which poses a financial burden to patients. As such, behavioral interventions aiming at monitoring and reducing oral behaviors could benefit a significant proportion of patients submitted to prosthetic rehabilitations as well.
Ecological momentary assessment (EMA) involves real-time and repeated assessments of phenomena (e.g., frequency of behaviors, mood states, symptoms etc.) over a period of time in naturalistic or ambulatory environments (15). In medicine and dentistry, EMA has been used to assist in the diagnosis of chronic pain disorders, including facial pains, such as migraine (6-18). By collecting specific features of a patient's symptoms (e.g., pain duration, intensity, location) on portable devices in real time, it is possible to develop temporal trajectories of those features, which can assist in achieving a clinical diagnosis, or study relationships between clinical symptoms and other variables (e.g., those related with lifestyle or the local environment).
EMA has been previously used in clinical research studies to assess the prevalence of oral behaviors in healthy individuals or in those affected with TMD, and to study facial pain temporal trajectories in individuals with chronic pain (16-17) (19-21). EMA studies have confirmed that individuals with TMD have more frequent oral behaviors than healthy controls (21-23). In the clinical realm, it is widely accepted that EMA interventions could be implemented to reduce the frequency of oral behaviors in patients with TMD pain. In fact, by providing real-time data and reports on an individual's frequency of oral behaviors, EMA could assist patients in monitoring and overcoming those oral behaviors (24). Notably, patient education through structured information about the detrimental effects of oral behaviors on the muscles of mastication and the temporomandibular joint (TMJ) has also been shown to be effective in reducing masticatory muscle activity and temporomandibular disorder (TMD) pain in the short term (12). Yet, whether EMA is more effective than structured information in reducing oral behaviors and masticatory muscle activity remains unclear. Although EMA interventions are conservative in nature, they can significantly disrupt an individual's daily life, as the EMA methodology requires the use of portable devices (such as tablets or mobile phones) to prompt an individual multiple times a day at random. As such, there is a need to understand whether this intervention is effective. Importantly, we lack information on the long-term effectiveness of EMA interventions. Of concern, individuals in specific job categories may be prevented from undergoing EMA interventions.
In this randomized clinical trial, we aim 1) to test the effects of a 1-week EMA intervention combined with structured information on the activity of the masseter muscle in individuals reporting highly frequent self-reported oral behaviors (high risk of TMD) (25), and 2) to determine whether a combined approach including an EMA intervention and structured information is more effective in reducing the activity of the masseter than structured information alone. We hypothesize that 1) EMA intervention + structured information will reduce the frequency of non-functional muscle contraction episodes (assessed with portable electromyography) only in the short-term, i.e., 1 week after its completion, and after one month, and 2) that EMA intervention combined with structured information will not be more effective than structured information alone.
REFERENCES. 1. Benoliel R. \& Sharav Y. Curr Pain Headache Rep 2010; 14:33-40; 2. National Institute of Dental And Craniofacial Research NIDCR, 2020; 3. Locker D. \& Slade G. Community Dent Oral Epidemiol. 1988;16:310-313; 4. Schiffman E. et al. J Oral Facial Pain Headache. 2014; 28:6-27; 5. Manfredini D. et al. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011; 112:453-462; 6. Slade G. et al. J Dent Res. 2016; 95: 1084-1092; 7. Maixner W. et al. J Pain. 2011;12: T4-8.e11-12. 13; 8. Fricton J.R. et al. Advances in Pain Research and Therapy; Orofacial Pain and Temporomandibular Disorders. New York: Raven Press; 1995; 9. National Academies of Sciences Engineering and Medicine. Temporomandibular Disorders: Priorities for Research and Care. Washington: The National Academies Press, 2020; 10. Manfredini D. \& Lobbezoo F. J Orofac Pain. 2009;23:153-166; 11. Cioffi I. et al. Clin Oral Investig. 2017; 21:1139-1148; 12. Donnarumma V. et al. J Oral Facial Pain Headache. 2022:36-48; 13. Durham J. J Oral Rehabil. 2016;43: 929-936; 14. Johansson A. J Prosthodont Res. 2011;55: 127-36; 15. Shiffman S. 2008;4:1-32; 16. Edefonti V. Community Dent Oral Epidemiol. 2012;40 Suppl 1:56-64; 17. Cioffi I, J Oral Rehabil. 2017;44:333-339; 18. Thomas JG. Cephalalgia. 2016;36:1228-1237. 19. Kaplan SE \& Ohrbach R. J Oral Facial Pain Headache. 2016;30:107-19; 20. Michelotti A. et al. J Dent Res. 2005;84:644-8; 21. Câmara-Souza M.B. et al. J Clin Med. 2023; 7;12:501; 22. Glaros A.G. et al. J Am Dent Assoc. 2005;136:451-8; 23. Glaros A.G. et al. Cranio. 2005;23:188-93; 24. Glaros A.G. et al. Appl Psychophysiol Biofeedback. 2007;32:149-54; 25. Ohrbach R. et al. J Pain. 2013;14(12 Suppl):T33-50; 26. Markiewicz M.R., et al. J Orofac Pain. 2006;20:306-16; 27. Ohrbach R. Eur J Oral Sci. 2008;116:438-44; 28. Cioffi I. et al. Clin Oral Investig. 2017;21:1139-1148. 29. Imbriglio T.V. et al. Headache. 2020;60:2389-2405; 30. Prasad S. et al. Clin Oral Investig. 2021;25:5049-5059; 31. Lou T et al.. Am J Orthod Dentofacial Orthop. 2021;159(1):e25-e33; 32. Chow J.C. \& Cioffi I. Clin Oral Investig. 2019; 23:1653-1661
- Conditions
- Temporomandibular Disorders (TMD), Bruxism, Masseter
- Being tested
- Educational video combined with daily surveys, Educational video only
- Keywords
- awake bruxism, temporomandibular disorders, masseter, oral behaviors, surface electromyography, tooth clenching
- Medical subject headings
- Temporomandibular Joint Disorders, Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational video combined with daily surveysBehavioural
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 onlyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Group A Receives: Behavioral: Educational video only |
| Standard of care combined with an ecological momentary assessment intervention | Experimental | Group B Receives: Behavioral: Educational video combined with daily surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of oral behaviors
Frequency of electromyographic (EMG) activity periods greater than 5 and 10% of participants' maximum voluntary contraction, measured using ambulatory EMG.
Measured: 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
Measured: after one week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start15 Apr 2025
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iacopo Cioffi, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022795
- Sponsor's protocol ID
- 46622
- Status last verified
- Jun 2025
- First submitted
- 7 Jun 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared with third parties, in accordance with the currently approved research ethics protocol.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Ecological Momentary Assessment Intervention to Reduce Masticatory Muscle Activity in Individuals at Risk for Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT07022795
- Acronym / sponsor ID
- 46622
- Conditions
- Temporomandibular Disorders (TMD), Bruxism, Masseter
- Keywords
- awake bruxism, temporomandibular disorders, masseter, oral behaviors, surface electromyography, tooth clenching
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Temporomandibular disorders (TMD) are the most common cause of nondental orofacial pain (1) and the second most frequent painful musculoskeletal (MSK) disorder after chronic low back pain (2). TMD affect 1/6 Canadians, mostly women (3). Painful TMD can affect the muscles of mastication and/or the temporomandibular joints (TMJs, i.e., the jaw joints), and are characterized primarily by spontaneous pain, or pain associated with jaw function, and TMJ sounds (e.g., clicking) (4). TMD pain affecting the muscles of mastication (TMD myalgia; mTMD) is the most common TMD (5). MTD mostly affect the two major muscles of mastication, i.e. the masseter and the temporalis. As in other painful MSK conditions, TMD cause considerable personal suffering, and pose a significant economic burden (6). In the USA ~$4 billion are spent annually, with >17.8 million lost work days/year for every 100 million working adults (7). Notably, ~85% of the cost of treating TMD is associated with clinical management of chronic mTMD. Despite the high prevalence of TMD, more than 30% of patients report pain for at least 5 years after treatment, regardless the treatment they had received (8) which suggests that treatments for TMD are ineffective. Consensus has been achieved in that conservative management strategies should be preferred over more invasive treatment approaches, such as prolonged pharmacological treatments or opioid use, which result in significant adverse effects that impact significantly on the quality of life of patients (9). Of importance, both laboratory and epidemiological studies indicated that oral behaviors - for example, awake bruxism, a stress-coping behavior characterized by repetitive or sustained tooth clenching(10)- might harm the muscles of mastication or the jaw joint (the temporomandibular joint, TMJ) by way of producing excessive forces to which these structures are exposed, potentially leading to, or exacerbating symptoms of TMD (11). Therefore, patient education focused on reducing the frequency of oral behaviors or awake bruxism has proven to be an effective first-line approach towards mTMD management (12-13). Notably, highly frequent oral behaviors and awake bruxism also can increase the risk of prosthetic failure (e.g., damage to restorations or crowns/bridges (14), which poses a financial burden to patients. As such, behavioral interventions aiming at monitoring and reducing oral behaviors could benefit a significant proportion of patients submitted to prosthetic rehabilitations as well.
Ecological momentary assessment (EMA) involves real-time and repeated assessments of phenomena (e.g., frequency of behaviors, mood states, symptoms etc.) over a period of time in naturalistic or ambulatory environments (15). In medicine and dentistry, EMA has been used to assist in the diagnosis of chronic pain disorders, including facial pains, such as migraine (6-18). By collecting specific features of a patient's symptoms (e.g., pain duration, intensity, location) on portable devices in real time, it is possible to develop temporal trajectories of those features, which can assist in achieving a clinical diagnosis, or study relationships between clinical symptoms and other variables (e.g., those related with lifestyle or the local environment).
EMA has been previously used in clinical research studies to assess the prevalence of oral behaviors in healthy individuals or in those affected with TMD, and to study facial pain temporal trajectories in individuals with chronic pain (16-17) (19-21). EMA studies have confirmed that individuals with TMD have more frequent oral behaviors than healthy controls (21-23). In the clinical realm, it is widely accepted that EMA interventions could be implemented to reduce the frequency of oral behaviors in patients with TMD pain. In fact, by providing real-time data and reports on an individual's frequency of oral behaviors, EMA could assist patients in monitoring and overcoming those oral behaviors (24). Notably, patient education through structured information about the detrimental effects of oral behaviors on the muscles of mastication and the temporomandibular joint (TMJ) has also been shown to be effective in reducing masticatory muscle activity and temporomandibular disorder (TMD) pain in the short term (12). Yet, whether EMA is more effective than structured information in reducing oral behaviors and masticatory muscle activity remains unclear. Although EMA interventions are conservative in nature, they can significantly disrupt an individual's daily life, as the EMA methodology requires the use of portable devices (such as tablets or mobile phones) to prompt an individual multiple times a day at random. As such, there is a need to understand whether this intervention is effective. Importantly, we lack information on the long-term effectiveness of EMA interventions. Of concern, individuals in specific job categories may be prevented from undergoing EMA interventions.
In this randomized clinical trial, we aim 1) to test the effects of a 1-week EMA intervention combined with structured information on the activity of the masseter muscle in individuals reporting highly frequent self-reported oral behaviors (high risk of TMD) (25), and 2) to determine whether a combined approach including an EMA intervention and structured information is more effective in reducing the activity of the masseter than structured information alone. We hypothesize that 1) EMA intervention + structured information will reduce the frequency of non-functional muscle contraction episodes (assessed with portable electromyography) only in the short-term, i.e., 1 week after its completion, and after one month, and 2) that EMA intervention combined with structured information will not be more effective than structured information alone.
REFERENCES. 1. Benoliel R. \& Sharav Y. Curr Pain Headache Rep 2010; 14:33-40; 2. National Institute of Dental And Craniofacial Research NIDCR, 2020; 3. Locker D. \& Slade G. Community Dent Oral Epidemiol. 1988;16:310-313; 4. Schiffman E. et al. J Oral Facial Pain Headache. 2014; 28:6-27; 5. Manfredini D. et al. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011; 112:453-462; 6. Slade G. et al. J Dent Res. 2016; 95: 1084-1092; 7. Maixner W. et al. J Pain. 2011;12: T4-8.e11-12. 13; 8. Fricton J.R. et al. Advances in Pain Research and Therapy; Orofacial Pain and Temporomandibular Disorders. New York: Raven Press; 1995; 9. National Academies of Sciences Engineering and Medicine. Temporomandibular Disorders: Priorities for Research and Care. Washington: The National Academies Press, 2020; 10. Manfredini D. \& Lobbezoo F. J Orofac Pain. 2009;23:153-166; 11. Cioffi I. et al. Clin Oral Investig. 2017; 21:1139-1148; 12. Donnarumma V. et al. J Oral Facial Pain Headache. 2022:36-48; 13. Durham J. J Oral Rehabil. 2016;43: 929-936; 14. Johansson A. J Prosthodont Res. 2011;55: 127-36; 15. Shiffman S. 2008;4:1-32; 16. Edefonti V. Community Dent Oral Epidemiol. 2012;40 Suppl 1:56-64; 17. Cioffi I, J Oral Rehabil. 2017;44:333-339; 18. Thomas JG. Cephalalgia. 2016;36:1228-1237. 19. Kaplan SE \& Ohrbach R. J Oral Facial Pain Headache. 2016;30:107-19; 20. Michelotti A. et al. J Dent Res. 2005;84:644-8; 21. Câmara-Souza M.B. et al. J Clin Med. 2023; 7;12:501; 22. Glaros A.G. et al. J Am Dent Assoc. 2005;136:451-8; 23. Glaros A.G. et al. Cranio. 2005;23:188-93; 24. Glaros A.G. et al. Appl Psychophysiol Biofeedback. 2007;32:149-54; 25. Ohrbach R. et al. J Pain. 2013;14(12 Suppl):T33-50; 26. Markiewicz M.R., et al. J Orofac Pain. 2006;20:306-16; 27. Ohrbach R. Eur J Oral Sci. 2008;116:438-44; 28. Cioffi I. et al. Clin Oral Investig. 2017;21:1139-1148. 29. Imbriglio T.V. et al. Headache. 2020;60:2389-2405; 30. Prasad S. et al. Clin Oral Investig. 2021;25:5049-5059; 31. Lou T et al.. Am J Orthod Dentofacial Orthop. 2021;159(1):e25-e33; 32. Chow J.C. \& Cioffi I. Clin Oral Investig. 2019; 23:1653-1661
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Behavioral: Educational video onlyGroup A |
| Standard of care combined with an ecological momentary assessment intervention | Experimental | Behavioral: Educational video combined with daily surveysGroup B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational video combined with daily surveysParticipants 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. | Behavioural | Standard of care combined with an ecological momentary assessment intervention |
| Educational video onlyParticipants 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. | Behavioural | Standard of care |
Primary outcome
Frequency of oral behaviors
Time frame: after one week intervention
Frequency of electromyographic (EMG) activity periods greater than 5 and 10% of participants' maximum voluntary contraction, measured using ambulatory EMG.
1 secondary outcome
Duration of oral behaviors
Time frame: after one week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared with third parties, in accordance with the currently approved research ethics protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Iacopo Cioffi Associate Professor, Principal investigator, DDS, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video combined with daily surveys and Educational video only in people with Temporomandibular Disorders (TMD) and Bruxism, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iacopo Cioffi Associate Professor, Principal investigator, DDS, PhD (+14168648107, iacopo.cioffi@dentistry.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of oral behaviors (time frame: after one week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.