Myalgia of Mastication Muscle, Myofacial Pain Syndromes, Orofacial Pain, Temporal Mandibular Joint Dysfunction, Temporomandibular Disorders (TMD)
Conditions
Keywords
Temporomandibular Disorders (TMD), Orofacial Pain, Telemonitoring, Teledentistry, Behavioral Therapy, Conservative Treatment
Brief summary
This prospective randomized clinical trial evaluates the effectiveness of a structured telemonitoring protocol as an adjunct to conservative management in patients with temporomandibular disorder (TMD)-related orofacial pain. Participants receive standardized conservative therapy based on behavioural counselling, habit reversal training, and home-based self-management exercises, with or without structured telemonitoring. Clinical outcomes include pain intensity, mandibular function, and oral behaviours, assessed over a 9-month follow-up period. The study aims to determine whether telemonitoring improves treatment adherence, behavioural modification, and clinical outcomes compared with conventional in-office follow-up.
Detailed description
This prospective randomized clinical trial evaluates the effectiveness of a structured telemonitoring protocol as an adjunct to conservative management in patients with temporomandibular disorder (TMD)-related orofacial pain. Participants receive standardized conservative therapy based on behavioural counselling, habit reversal training, and home-based self-management exercises, with or without structured telemonitoring. Clinical outcomes include pain intensity, mandibular function, and oral behaviours, assessed over a 9-month follow-up period. The study aims to determine whether telemonitoring improves treatment adherence, behavioural modification, and clinical outcomes compared with conventional in-office follow-up.
Interventions
BEHAVIORALStructured Telemonitoring
Weekly remote monitoring through text messaging and scheduled video consultations, in addition to standard conservative management.
BEHAVIORALConservative Management
Behavioural counselling, habit reversal training, and home-based self-management exercises with monthly in-office follow-up.
Sponsors
University Magna Graecia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-80 years. * Diagnosis of temporomandibular disorder (TMD) according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). * Presence of chronic orofacial pain persisting for more than 30 days. * Diagnosis of myofascial pain involving the masticatory muscles, with or without headache attributed to TMD. * Ability to use a mobile device compatible with telemonitoring procedures.
Exclusion criteria
* Systemic diseases affecting pain perception or neuromuscular function (including autoimmune, neurological, or neoplastic disorders). * History of severe orofacial trauma. * Previous major temporomandibular joint surgery. * Ongoing orthodontic treatment. * Current use of occlusal splints. * Current use of muscle relaxants or psychoactive medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum pain-free mouth opening (mm) | Baseline (T0), 3 months (T1), and 9 months (T2) | Change in maximum pain-free mouth opening measured in millimetres (mm) as an indicator of mandibular functional improvement. |
| Mandibular lateral excursions (mm) | Baseline (T0), 3 months (T1), and 9 months (T2) | Change in right and left mandibular lateral excursion measured in millimetres (mm). |
| Protrusive movement (mm) | Baseline (T0), 3 months (T1), and 9 months (T2) | Change in maximum mandibular protrusive movement measured in millimetres (mm). |
| Pain intensity assessed using the Visual Analogue Scale (VAS) | Baseline (T0), 3 months (T1), and 9 months (T2) | Change in perceived pain intensity assessed using a 10-cm Visual Analogue Scale (VAS), where higher scores indicate greater pain intensity. Scale range is 0 to 10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oral Behaviours Checklist (OBC) score | Baseline (T0), 3 months (T1), and 9 months (T2) | Change in the frequency of oral parafunctional behaviours assessed using the Oral Behaviours Checklist (OBC). Higher scores indicate a greater frequency of reported oral behaviours. Scale range is 0 to 84. |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORSELENE BARONE, PhDs, DDS
Magna Graecia University of Catanzaro
Outcome results
None listed