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

NCT07095101 | Not Yet Recruiting

• 1 other identifier: Dnr 2024-05598-01
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Temporomandibular Joint Disorder; Temporomandibular Disorders (TMDs)

Keywords

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

Outcome Measures

Primary Outcomes (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.

  From enrolment to 3 month follow-up

Secondary Outcomes (4)

• Cost-effectiveness

  From enrolment to 3 month follow-up

• Stress-levels

  From enrolment to 3 month follow-up

• Changes in general well-being

  From enrolment to 3 month follow-up

• Correlation between pain and overload

  From enrolment to 3 month follow-up

Other Outcomes (3)

• Coping

  From enrolment to 3 month follow-up

• Headache

  From enrolment to 3 month follow-up

• Widespread pain

  From enrolment to 3 month follow-up

Study Arms (3)

Mobistudy Application

EXPERIMENTAL

Treatment with mobile application

Behavioral: Mobistudy Application

Occlusal splint

ACTIVE COMPARATOR

Treatment with an occlusal splint

Device: Occlusal splint

Waiting list

NO INTERVENTION

Waiting list followed by delayed intervention with mobile application

Interventions

Mobistudy Application BEHAVIORAL

Treatment with mobile application

Mobistudy Application

Occlusal splint DEVICE

Treatment with an occlusal splint

Occlusal splint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Malmö University: lead
• Folktandvården Skåne AB: collaborator

Related Publications (4)

• 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.

  PMID: 37210658 BACKGROUND

• 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.

  PMID: 19646331 BACKGROUND

• 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.

  PMID: 32701837 BACKGROUND

• 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.

  PMID: 16095934 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Myalgia; Facial Pain; Bruxism

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Diseases; Habits; Behavior

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Birgitta Häggman-Henrikson, DDS, PhD

  Malmö University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 31, 2025
• Study Start: August 22, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share