Telemonitoring for TMD-Related Pain

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

Registry ID: NCT07764770
Source registry: NCT
Status: COMPLETED
Phase: NA
Study type: INTERVENTIONAL
Sponsor: University Magna Graecia
Enrollment: 60
Start date: 2025-01-01
Completion date: 2026-07-15
Last update: 2026-08-14

Conditions

Temporal Mandibular Joint Dysfunction
Orofacial Pain
Myofacial Pain Syndromes
Myalgia of Mastication Muscle
Temporomandibular Disorders (TMD)

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

Interventions

BEHAVIORAL: Structured Telemonitoring
BEHAVIORAL: Conservative Management

Inclusion criteria

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

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.

Primary outcomes

[{"measure":"Maximum pain-free mouth opening (mm)","timeFrame":"Baseline (T0), 3 months (T1), and 9 months (T2)"},{"measure":"Mandibular lateral excursions (mm)","timeFrame":"Baseline (T0), 3 months (T1), and 9 months (T2)"},{"measure":"Protrusive movement (mm)","timeFrame":"Baseline (T0), 3 months (T1), and 9 months (T2)"},{"measure":"Pain intensity assessed using the Visual Analogue Scale (VAS)","timeFrame":"Baseline (T0), 3 months (T1), and 9 months (T2)"}]

Locations

Magna Graecia University of Catanzaro, Catanzaro, Italy

Publications

Sycinska-Dziarnowska M, Maglitto M, Wozniak K, Spagnuolo G. Oral Health and Teledentistry Interest during the COVID-19 Pandemic. J Clin Med. 2021 Aug 11;10(16):3532. doi: 10.3390/jcm10163532.
Manfredini D, Lombardo L, Siciliani G. Temporomandibular disorders and dental occlusion. A systematic review of association studies: end of an era? J Oral Rehabil. 2017 Nov;44(11):908-923. doi: 10.1111/joor.12531. Epub 2017 Jul 2.
Saini RS, Chopra S, Assiri YA, Alhamoudi FH, Vaddamanu SK, Chaturvedi M, Kuruniyan MS, Banakar M, Heboyan A. Impact of mHealth and eHealth on oral health literacy: A systematic review. Digit Health. 2025 Jul 21;11:20552076251360955. doi: 10.1177/20552076251360955. eCollection 2025 Jan-Dec.
Ohrbach R, Michelotti A. The Role of Stress in the Etiology of Oral Parafunction and Myofascial Pain. Oral Maxillofac Surg Clin North Am. 2018 Aug;30(3):369-379. doi: 10.1016/j.coms.2018.04.011. Epub 2018 Jun 1.
Ohrbach R, Dworkin SF. The Evolution of TMD Diagnosis: Past, Present, Future. J Dent Res. 2016 Sep;95(10):1093-101. doi: 10.1177/0022034516653922. Epub 2016 Jun 16.
Iodice G, Michelotti A, D'Anto V, Martina S, Valletta R, Rongo R. Prevalence of psychosocial findings and their correlation with TMD symptoms in an adult population sample. Prog Orthod. 2024 Oct 14;25(1):39. doi: 10.1186/s40510-024-00538-y.
Peck CC, Goulet JP, Lobbezoo F, Schiffman EL, Alstergren P, Anderson GC, de Leeuw R, Jensen R, Michelotti A, Ohrbach R, Petersson A, List T. Expanding the taxonomy of the diagnostic criteria for temporomandibular disorders. J Oral Rehabil. 2014 Jan;41(1):2-23. doi: 10.1111/joor.12132.
Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
Ben El Hammi N, Amessegher F, Moudni S, Jouhadi EM. Physiotherapy Approaches for Temporomandibular Disorders: A Multimodal Conservative Management Strategy. Cureus. 2025 Jul 28;17(7):e88885. doi: 10.7759/cureus.88885. eCollection 2025 Jul.

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