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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Weekly remote monitoring through text messaging and scheduled video consultations, in addition to standard conservative management.
Behavioural counselling, habit reversal training, and home-based self-management exercises with monthly in-office follow-up.
Magna Graecia University of Catanzaro
Catanzaro, CZ, Italy
Maximum pain-free mouth opening (mm)
Change in maximum pain-free mouth opening measured in millimetres (mm) as an indicator of mandibular functional improvement.
Time frame: Baseline (T0), 3 months (T1), and 9 months (T2)
Mandibular lateral excursions (mm)
Change in right and left mandibular lateral excursion measured in millimetres (mm).
Time frame: Baseline (T0), 3 months (T1), and 9 months (T2)
Protrusive movement (mm)
Change in maximum mandibular protrusive movement measured in millimetres (mm).
Time frame: Baseline (T0), 3 months (T1), and 9 months (T2)
Pain intensity assessed using the Visual Analogue Scale (VAS)
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.
Time frame: Baseline (T0), 3 months (T1), and 9 months (T2)
Oral Behaviours Checklist (OBC) score
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.
Time frame: Baseline (T0), 3 months (T1), and 9 months (T2)
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