Temporomandibular Disorders (TMD)NCT07764770
Telemonitoring for TMD-Related Pain
A study testing Structured Telemonitoring and Conservative Management in people with Temporomandibular Disorders (TMD) and Orofacial Pain, run by University Magna Graecia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Temporomandibular Disorders (TMD), Orofacial Pain, Myofacial Pain Syndromes
- What is being tested?
- Structured Telemonitoring and Conservative Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2025to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Structured Telemonitoring as an Adjunct to Conservative Management of Temporomandibular Disorder-Related Orofacial Pain: A Randomized Clinical Trial
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.
- Conditions
- Temporomandibular Disorders (TMD), Orofacial Pain, Myofacial Pain Syndromes, Myalgia of Mastication Muscle, Temporal Mandibular Joint Dysfunction
- Being tested
- Structured Telemonitoring, Conservative Management
- Keywords
- Temporomandibular Disorders (TMD), Orofacial Pain, Telemonitoring, Teledentistry, Behavioral Therapy, Conservative Treatment
- Medical subject headings
- Temporomandibular Joint Disorders, Facial Pain, Facial Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured TelemonitoringBehavioural
Weekly remote monitoring through text messaging and scheduled video consultations, in addition to standard conservative management.
Conservative ManagementBehavioural
Behavioural counselling, habit reversal training, and home-based self-management exercises with monthly in-office follow-up.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Conservative Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum pain-free mouth opening (mm)
Change in maximum pain-free mouth opening measured in millimetres (mm) as an indicator of mandibular functional improvement.
Measured: 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).
Measured: Baseline (T0), 3 months (T1), and 9 months (T2)
Protrusive movement (mm)
Change in maximum mandibular protrusive movement measured in millimetres (mm).
Measured: 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. Scale range is 0 to 10.
Measured: 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.
Measured: Baseline (T0), 3 months (T1), and 9 months (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Jan 2025
- Primary completion1 Jun 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amerigo Giudice, University Magna Graecia
- Investigators
- SELENE BARONE, PhDs, DDS, Principal investigator, Magna Graecia University of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764770
- Sponsor's protocol ID
- 268/2021
- Status last verified
- Jan 2021
- First submitted
- 10 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 40881526Iodice 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 39397187Ohrbach 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 29866454Sycinska-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 34441828Saini 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 40718406Ohrbach 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 27313164Schiffman 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 24482784Peck 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 24443898Manfredini 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Telemonitoring as an Adjunct to Conservative Management of Temporomandibular Disorder-Related Orofacial Pain: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07764770
- Acronym / sponsor ID
- 268/2021
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring group (TG) | Experimental | Behavioral: Structured TelemonitoringThe TG received an active management protocol consisting of standard myofascial therapy combined with monthly in-office clinical evaluations and weekly structured remote interactions. |
| Control group (CG) | Active comparator | Behavioral: Conservative ManagementCG received conventional care based on monthly in-office clinical follow-up and standard therapeutic instructions without any form of remote monitoring. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured TelemonitoringWeekly remote monitoring through text messaging and scheduled video consultations, in addition to standard conservative management. | Behavioural | Telemonitoring group (TG) |
| Conservative ManagementBehavioural counselling, habit reversal training, and home-based self-management exercises with monthly in-office follow-up. | Behavioural | Control group (CG) |
Primary outcome
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.
1 secondary outcome
Oral Behaviours Checklist (OBC) score
Time frame: Baseline (T0), 3 months (T1), and 9 months (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Background: PubMed 40881526Ben 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.
- Background: PubMed 39397187Iodice 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.
- Background: PubMed 29866454Ohrbach 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.
- Background: PubMed 34441828Sycinska-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.
- Background: PubMed 40718406Saini 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.
- Background: PubMed 27313164Ohrbach 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.
- Background: PubMed 24482784Schiffman 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.
- Background: PubMed 24443898Peck 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.
- Background: PubMed 28600812Manfredini 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.
- Individual participant dataSharing planned: No
Related trials for Temporomandibular Disorders (TMD)
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
Recruiting
Clinical and Electromyographic Assessment of Occlusal Splint Therapy
Temporomandibular Joint Disorders
Recruiting
An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders
Temporomandibular Disorder, Orofacial Pain
Enrolling by invitationObservational study
Long-term Safety and Performance of Materialise's Patient-specific TMJ System.
Temporomandibular Joint Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SELENE BARONE, PhDs, DDS principal investigator
Magna Graecia University of Catanzaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Telemonitoring and Conservative Management in people with Temporomandibular Disorders (TMD) and Orofacial Pain, run by University Magna Graecia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum pain-free mouth opening (mm) (time frame: Baseline (T0), 3 months (T1), and 9 months (T2)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07764770, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.