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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07095101
Acronym
ePROPP
Enrollment
120
Registered
2025-07-31
Start date
2025-08-22
Completion date
2028-12-31
Last updated
2025-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Disorders (TMDs), Temporomandibular Joint Disorder

Keywords

Temporomandibular Disorders (TMDs), Myalgia, Facial Pain, Behavior therapy, Telemedicine, Digital health, Occlusal splints, Cost-effectiveness analysis, Bruxism, Mobile applications, Cognitive Behavioral Therapy

Brief 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. 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.

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.

Interventions

BEHAVIORALMobistudy Application

Treatment with mobile application

DEVICEOcclusal splint

Treatment with an occlusal splint

Sponsors

Folktandvården Skåne AB
CollaboratorOTHER
Malmö University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in pain intensityFrom enrolment to 3 month follow-upPain 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.

Secondary

MeasureTime frameDescription
Stress-levelsFrom enrolment to 3 month follow-upAssessment 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).
Cost-effectivenessFrom enrolment to 3 month follow-upCost-effectiveness will be assessed using direct and indirect costs to calculate total societal costs for the two different interventions
Changes in general well-beingFrom enrolment to 3 month follow-upAssessment 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.
Correlation between pain and overloadFrom enrolment to 3 month follow-upDuring 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).

Other

MeasureTime frameDescription
Widespread painFrom enrolment to 3 month follow-upWidespread pain will be assessed by a pain manikin.
HeadacheFrom enrolment to 3 month follow-upAssessment with the Headache screening questionnaire (HSQ). The HSQ aims to identify individuals who might have migraine or tension type headache by assessing headache characteristics across four domains: frequency, duration, characteristics, and symptoms.
CopingFrom enrolment to 3 month follow-upCoping will be assessed with the Brief Resilience Coping Scale (BRCS-4) using a 5-point Likert scale for each item, ranging from Does not describe me at all to Describes me very well. The total score is calculated by summing the responses to all four items. Higher scores indicate a greater tendency toward resilient coping.

Contacts

Primary ContactBirgitta Häggman-Henrikson, DDS, PhD
Birgitta.haggman.henrikson@mau.se46-70-455 94 01
Backup ContactAya Al-Salih, DDS
Aya.al-salih@mau.se46-72-280 81 24

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026