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AzTrials

Temporomandibular Joint DisorderePROPPNCT07095101

ePROPP - eHealth for Preventing and Reducing Orofacial Pain in the Population

A study testing Mobistudy Application and Occlusal splint in people with Temporomandibular Joint Disorder and Temporomandibular Disorders (TMDs), run by Malmö University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Pain in the orofacial region has a 10% prevalence in the general population and health care providers are therefore expected to encounter these patients on a daily basis. Chronic orofacial pain often presents as jaw pain related to overload of the jaw muscles and temporomandibular joints. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Mobistudy Application and Occlusal splint
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
22 Aug 2025to 31 Dec 2028
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic orofacial pain, duration ≥3 months with a diagnosis of Myalgia according to the brief DC/TMD.
  • Patients will be included even if they have one or more additional DC/TMD diagnoses
  • Regular smartphone users
  • Understanding written and spoken Swedish
  • Age ≥ 18 years

Who cannot join

  • Other orofacial non-TMD pain conditions
  • Cognitive impairment.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Birgitta Häggman-Henrikson, DDS, PhD contact

46-70-455 94 01

Birgitta.haggman.henrikson@mau.se

Aya Al-Salih, DDS contact

46-72-280 81 24

Aya.al-salih@mau.se

About this study

Official title: Effect and Cost-effectiveness of Smartphone-based Behavioural Intervention on Orofacial Pain

Pain in the orofacial region has a 10% prevalence in the general population and health care providers are therefore expected to encounter these patients on a daily basis. Chronic orofacial pain often presents as jaw pain related to overload of the jaw muscles and temporomandibular joints. The aim of this study is to evaluate the effectiveness of a smartphone-based behavioural intervention (Ecological Momentary Intervention, EMI) grounded in Cognitive Behavioural Therapy (CBT), compared to standard treatment with an occlusal splint and a waiting list control group.

Read the detailed description

The World Health Organization (WHO) emphasizes oral health as a key indicator of overall wellbeing. Poor oral health, especially when associated with pain, severely impacts individuals by reducing their quality of life. Orofacial pain is the third most common chronic pain, after knee and neck/back pain, and affects more than 10% of the adult population worldwide. In common with other chronic pain conditions, orofacial pain is a multi-factorial condition involving biological, psychological, and social factors - all encompassed in the biopsychosocial model. Contributing factors to pain, such as stress and anxiety are increasing, highlighting the need to identify and manage patients to counteract this growing problem. One potential risk factor for orofacial pain is muscle and joint overload due to stress-related tooth clenching and grinding. It is therefore important to evaluate and modify behaviours related to such overload.

Shortage of resources results in many patients not receiving treatment. In addition to the suffering experienced by affected individuals, chronic pain also significantly impacts family members, and leads to increased healthcare costs and a substantial societal burden.

Effective treatments, such as cognitive behavioural therapy (CBT), are available, but time-consuming, requiring repeated visits to care providers. Consequently, the incorporation of eHealth solutions utilizing mobile technology and internet-based therapy has been recommended. The implementation of eHealth, defined as "the use of information and communications technology in support of health and health-related fields" is advocated by the WHO to "accelerate global attainment of health and wellbeing". The recent development of smartphone and internet-based applications offers a promising avenue for cost-effectiveness and equity in health care

Traditional treatment of orofacial pain with oral splints requires repeated dental visits and incur significant costs together with additional technician costs for splint fabrication. A digital behavioural intervention could offer a drastically more cost-effective solution, reduce patients' suffering and the number of treatment visits, thereby easing the burden on the current waiting lists for patients with orofacial pain that in many regions can be a year or more. The project will investigate whether digital behavioural intervention can serve as a cost-effective alternative to traditional occlusal splint therapy for managing orofacial pain. By integrating real-time data collection and intervention, patients can be offered personalized, accessible treatment that seamlessly integrate into daily life. The availability of cost-effective eHealth solutions is especially relevant in regions with limited access to health care due to geographical distances or shortage of health care providers. Moreover, eHealth medical care can also be invaluable in situations for patients who are homebound for any reason.

This project aims to gain unique knowledge into the core mechanisms of pain and evaluate a novel multimodal person-centred eHealth approach for management of orofacial pain.

The overarching goal is to develop and evaluate a cost-effective eHealth tool for management of orofacial pain in collaboration with health care providers, facilitating large scale implementation in the population. The non-inferiority hypothesis: Treatment with a smartphone based behavioural intervention is not inferior to treatment with occlusal splint.

The superiority hypothesis: Compared to waiting list, a smartphone based behavioural intervention can reduce orofacial pain.

The results from this project can enable a broad implementation of an eHealth treatment that conserves resources, helping to address the current resource shortages in healthcare.

Being tested
Mobistudy Application, Occlusal splint
Keywords
Temporomandibular Disorders (TMDs), Myalgia, Facial Pain, Behavior therapy, Telemedicine, Digital health, Occlusal splints, Cost-effectiveness analysis, Bruxism, Mobile applications, Cognitive Behavioral Therapy
Medical subject headings
Temporomandibular Joint Disorders, Myalgia, Facial Pain, Bruxism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobistudy ApplicationBehavioural

    Treatment with mobile application

  • Occlusal splintDevice

    Treatment with an occlusal splint

Study groups in NCT07095101
Study groupRoleWhat they receive
Mobistudy ApplicationExperimentalTreatment with mobile application
Receives: Behavioral: Mobistudy Application
Occlusal splintActive comparatorTreatment with an occlusal splint
Receives: Device: Occlusal splint
Waiting listNo interventionWaiting list followed by delayed intervention with mobile application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in pain intensity

    Pain level will be assessed using the Numeric rating Scale (NRS, a scale ranging from 0 (no pain) to 10 (worst pain imaginable). A 30% reduction in pain according to the NRS is considered a significant effect.

    Measured: From enrolment to 3 month follow-up

Secondary outcomes (4)
  1. Cost-effectiveness

    Cost-effectiveness will be assessed using direct and indirect costs to calculate total societal costs for the two different interventions

    Measured: From enrolment to 3 month follow-up

  2. Stress-levels

    Assessment of stress will be done using the Perceived stress-scale (PSS-10) which yields a total score from 0 to 40, calculated by summing responses to 10 items, each scored on a 5-point Likert scale (0 = never to 4 = very often).

    Measured: From enrolment to 3 month follow-up

  3. Changes in general well-being

    Assessment of general wellbeing will be done with Patient Health Questionnaire (PHQ-4) which combines two 2-item scales: the PHQ-2 (depression) and the GAD-2 (anxiety). Each question is scored on a 4-point Likert scale (0-3), and the total score is the sum of all four items Higher scores indicate a greater severity of symptoms.

    Measured: From enrolment to 3 month follow-up

  4. Correlation between pain and overload

    During the first 3 days of using the mobistudy application, the relation between muscluskeletal overload and TMD-pain will be assessed..

    Assessment of overload with Ecological momentary assessment of self-reported overload will be correlated (Spearman's correlated) to pain intensity using the Numeric rating Scale (NRS), a scale ranging from 0 (no pain) to 10 (worst pain imaginable).

    Measured: From enrolment to 3 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2025
  2. Study start22 Aug 2025 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07095101
Sponsor's protocol ID
Dnr 2024-05598-01
Acronym
ePROPP
Status last verified
Jul 2025
First submitted
14 Jul 2025
Last updated
5 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Restrictions related to sensitive personal data and ethical approval

Publications

  • Stanisic N, Do CT, Skarping S, Chrcanovic B, Bracci A, Manfredini D, Haggman-Henrikson B. Smartphone application to report awake bruxism: Development and testing of the Swedish version and a pilot study to evaluate family history in young adults and their parents. J Oral Rehabil. 2024 Jan;51(1):188-195. doi: 10.1111/joor.13515. Epub 2023 May 29.

    PubMed 37210658
  • Heron KE, Smyth JM. Ecological momentary interventions: incorporating mobile technology into psychosocial and health behaviour treatments. Br J Health Psychol. 2010 Feb;15(Pt 1):1-39. doi: 10.1348/135910709X466063. Epub 2009 Jul 28.

    PubMed 19646331
  • Haggman-Henrikson B, Liv P, Ilgunas A, Visscher CM, Lobbezoo F, Durham J, Lovgren A. Increasing gender differences in the prevalence and chronification of orofacial pain in the population. Pain. 2020 Aug;161(8):1768-1775. doi: 10.1097/j.pain.0000000000001872. Epub 2020 Mar 16.

    PubMed 32701837
  • Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006 May;10(4):287-333. doi: 10.1016/j.ejpain.2005.06.009. Epub 2005 Aug 10.

    PubMed 16095934

Questions about this trial

What is this clinical trial studying?

A study testing Mobistudy Application and Occlusal splint in people with Temporomandibular Joint Disorder and Temporomandibular Disorders (TMDs), run by Malmö University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. 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: opening soon, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

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 Birgitta Häggman-Henrikson, DDS, PhD (46-70-455 94 01, Birgitta.haggman.henrikson@mau.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain intensity (time frame: From enrolment to 3 month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07095101, which also lists 4 linked publications.

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 5 Aug 2025.

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