Telemonitoring for TMD-Related Pain

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.

• Structured Telemonitoring (Behavioral): Weekly remote monitoring through text messaging and scheduled video consultations, in addition to standard conservative management.
• Conservative Management (Behavioral): Behavioural counselling, habit reversal training, and home-based self-management exercises with monthly in-office follow-up.

Primary outcomes

• 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 outcomes

• 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.

Sex: All, ages: 18 Years to 80 Years

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.

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• SELENE BARONE, PhDs, DDS, Principal investigator, Magna Graecia University of Catanzaro