ClinicalTrials.gg
CompletedNCT07764770Updated Aug 21, 2026

Telemonitoring for TMD-Related Pain

An interventional study of Structured Telemonitoring and Conservative Management in Temporomandibular Disorders (TMD), Orofacial Pain and Myofacial Pain Syndromes, sponsored by University Magna Graecia. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by University Magna Graecia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Jan 2025, registered Aug 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Temporomandibular Joint Disorders

591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.

This study's enrollment of 60 is above the median of 45 across 415 interventional studies indexed under Temporomandibular Joint Disorders.

Browse Temporomandibular Joint Disorders studies →

Lead sponsor

University Magna Graecia is the lead sponsor of 75 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 , 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Structured Telemonitoring

  • Active comparator
    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.

    Behavioral: Conservative Management

Interventions

  • BehavioralStructured Telemonitoring

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

  • BehavioralConservative Management

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

06

What researchers measure

Primary outcomes

  1. 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)

  2. 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)

  3. Protrusive movement (mm)

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

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

  4. 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)

Secondary outcomes

  1. 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)

07

Study locations

1 site
  • Magna Graecia University of Catanzaro
    Catanzaro, CZ 88100, Italy
08

References and documents

Publications

  • 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. PubMed 40881526 ↗
  • 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. PubMed 39397187 ↗
  • 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. PubMed 29866454 ↗
  • 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. PubMed 34441828 ↗
  • 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. PubMed 40718406 ↗
  • 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. PubMed 27313164 ↗
  • 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. PubMed 24482784 ↗
  • 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. PubMed 24443898 ↗
  • 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. PubMed 28600812 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2025 to primary completion in Jun 2026, 17 months.

Of 242 non-industry interventional studies with no phase under Temporomandibular Joint Disorders, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's 17 months is above that.

Counting every sponsor, half of 246 studies reached it within 10 months; a quarter within 5 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2026
First posted
Aug 14, 2026
StartActual
Jan 1, 2025
Primary completionActual
Jun 1, 2026
CompletionActual
Jul 15, 2026
Last update
Aug 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07764770
Lead sponsor
University Magna Graecia
Responsible party
Amerigo Giudice (Professor, University Magna Graecia) — Principal investigator
First posted
Aug 14, 2026
Start date
Jan 1, 2025
Primary completion
Jun 1, 2026
Completion
Jul 15, 2026
Last update
Aug 21, 2026

Study contacts

SELENE BARONE, PhDs, DDS
principal investigator · Magna Graecia University of Catanzaro

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion