Structured Telemonitoring as an Adjunct to Conservative Management of Temporomandibular Disorder-Related Orofacial Pain: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Maximum pain-free mouth opening (mm)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Telemonitoring group (TG)
The TG received an active management protocol consisting of standard myofascial therapy combined with monthly in-office clinical evaluations and weekly structured remote interactions.
Intervention: Structured Telemonitoring (Behavioral)
Control group (CG)
CG received conventional care based on monthly in-office clinical follow-up and standard therapeutic instructions without any form of remote monitoring.
Intervention: Conservative Management (Behavioral)
Outcomes
Primary Outcomes
Maximum pain-free mouth opening (mm)
Time Frame: 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)
Time Frame: Baseline (T0), 3 months (T1), and 9 months (T2)
Change in right and left mandibular lateral excursion measured in millimetres (mm).
Protrusive movement (mm)
Time Frame: 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)
Time Frame: 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))
Investigators
Amerigo Giudice
Professor
University Magna Graecia