Telemonitoring for TMD-Related Pain

NCT07764770 | Completed

• 1 other identifier: 268/2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Temporomandibular Disorders (TMD); Orofacial Pain; Telemonitoring, Teledentistry; Behavioral Therapy; Conservative Treatment

Outcome Measures

Primary Outcomes (4)

• Maximum pain-free mouth opening (mm)

  Change in maximum pain-free mouth opening measured in millimetres (mm) as an indicator of mandibular functional improvement.

  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).

  Baseline (T0), 3 months (T1), and 9 months (T2)

• Protrusive movement (mm)

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

  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.

  Baseline (T0), 3 months (T1), and 9 months (T2)

Secondary Outcomes (1)

• Oral Behaviours Checklist (OBC) score

  Baseline (T0), 3 months (T1), and 9 months (T2)

Study Arms (2)

Telemonitoring group (TG)

EXPERIMENTAL

The TG received an active management protocol consisting of standard myofascial therapy combined with monthly in-office clinical evaluations and weekly structured remote interactions.

Behavioral: Structured Telemonitoring

Control group (CG)

ACTIVE COMPARATOR

CG received conventional care based on monthly in-office clinical follow-up and standard therapeutic instructions without any form of remote monitoring.

Behavioral: Conservative Management

Interventions

Structured Telemonitoring BEHAVIORAL

Weekly remote monitoring through text messaging and scheduled video consultations, in addition to standard conservative management.

Telemonitoring group (TG)

Conservative Management BEHAVIORAL

Behavioural counselling, habit reversal training, and home-based self-management exercises with monthly in-office follow-up.

Control group (CG)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

Magna Graecia University of Catanzaro

Catanzaro, CZ, 88100, Italy

Location

Related Publications (9)

• 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.

  PMID: 40881526 BACKGROUND

• 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.

  PMID: 39397187 BACKGROUND

• 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.

  PMID: 29866454 BACKGROUND

• 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.

  PMID: 34441828 BACKGROUND

• 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.

  PMID: 40718406 BACKGROUND

• 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.

  PMID: 27313164 BACKGROUND

• 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.

  PMID: 24482784 BACKGROUND

• 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.

  PMID: 24443898 BACKGROUND

• 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.

  PMID: 28600812 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Facial Pain; Facial Neuralgia

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Facial Nerve Diseases; Mouth Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• SELENE BARONE, PhDs, DDS

  Magna Graecia University of Catanzaro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start: January 1, 2025
• Primary Completion: June 1, 2026
• Study Completion: July 15, 2026
• Last Updated: August 14, 2026

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)