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Completed

NCT Number: NCT07764770

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.

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Key information

Conditions

Temporomandibular Disorders (TMD) Cranial Nerve Diseases Craniomandibular Disorders Facial Nerve Diseases Facial Neuralgia Facial Pain Jaw Diseases Joint Diseases Mandibular Diseases Mouth Diseases Muscular Diseases Musculoskeletal Diseases Myalgia of Mastication Muscle Myofacial Pain Syndromes Nervous System Diseases Neurologic Manifestations Orofacial Pain Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Temporal Mandibular Joint Dysfunction Temporomandibular Joint Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Magna Graecia University of Catanzaro

Catanzaro, CZ, 88100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. 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.

  2. 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).

  3. Protrusive movement (mm)

    Time frame: Baseline (T0), 3 months (T1), and 9 months (T2)

    Change in maximum mandibular protrusive movement measured in millimetres (mm).

  4. 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.

Secondary outcomes

  1. Oral Behaviours Checklist (OBC) score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Magna Graecia

Other

Registry information

Official study title

Structured Telemonitoring as an Adjunct to Conservative Management of Temporomandibular Disorder-Related Orofacial Pain: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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