TMDBENEFITNCT02946645

Efficiency of Neuromuscular Bite vs Physiotherapy in TMD Patients

A study testing Neuromuscular Bite (orthotic/sub-lingual) and Mandibular Physiotherapy in people with TMD, run by University of L'Aquila at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Temporomandibular joint dysfunction (TMD) therapy remains an open challenge for modern dentistry. Usually physiotherapy is considered a reliable approach to treatment of TMD patients. Moreover, neuromuscular bites (orthotic) are able to reduce signs and symptoms of TMD. Read more about this study

Who is it for?: Ages 25 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: TMD
What is being tested?: Neuromuscular Bite (orthotic/sub-lingual) and Mandibular Physiotherapy
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 63 participants
Where: 1 siteItaly
Study dates: Oct 2016to 31 Dec 2020
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 25 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

myogenous TMD;
pain duration longer than 3 months;
presence of complete permanent dentition, with the possible exception of the third molars;
normal occlusion.

Who cannot join

Patients were excluded from the study if they met one or more of the following criteria:
presence of systemic or metabolic diseases;
eye diseases or visual defects;
history of local or general trauma;
neurological or psychiatric disorders;
muscular diseases;

Show all 14Show fewer

cervical pain;
bruxism, as diagnosed by the presence of parafunctional facets and/or anamnesis of parafunctional tooth clenching and/or grinding;
pregnancy;
assumed use of anti-inflammatory, analgesic, anti-depressant, opioid, or myorelaxant - - drugs;
smoking;
fixed or removable prostheses;
fixed restorations that affected the occlusal surfaces;
and either previous or concurrent orthodontic or orthognathic treatment. For comparison with previous literature, the diagnosis of myofascial-type TMD was provided after clinical examination by a trained clinician according to group 1a and 1b of the Research Diagnostic Criteria for TMD (RDC/TMD), in a blinded manner

Trial locations and contacts

1 site in 1 country.

Italy1 site

Dental Clinic, University of L'Aquila, St. Salvatore Hospital,
L’Aquila, 67100

Other trials in Italy

About this study

Official title: Efficiency of Neuromuscular Bite vs Physiotherapy in TMD Patients BENEFIT Study

The aim of this trial is to evaluate the efficiency in term of cranial muscles electromyography (sEMG), mandibular kinetic (KNG) and subjective pain scores, of orthotic vs manual physiotherapy therapy compared to placebo.

Conditions: TMD
Being tested: Neuromuscular Bite (orthotic/sub-lingual), Mandibular Physiotherapy, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Neuromuscular Bite (orthotic/sub-lingual)Device
Bite is a device which simulates a set of properly positioned teeth
Mandibular PhysiotherapyProcedure or surgery
Mandibular Stabilisation Exercises
1. Place knuckle of index finger between top and bottom teeth.
2. Remove it, keeping the teeth separated one-knuckle apart.
3. Apply gentle pressure to the to the jaw using your index finger/thumb as demonstrated in the pictures above.
PlaceboOther
No interventions.

Study groups in NCT02946645
Study group	Role	What they receive
Manual Physiotherapy	Active comparator	TMD patients will treat with orofacial physiotherapy by one expert operator according to literature Receives: Procedure: Mandibular Physiotherapy
Neuromuscular Bite	Active comparator	TMD patients will receive an intraoral neuromuscular bite according to literature Receives: Device: Neuromuscular Bite (orthotic/sub-lingual)
Placebo	Placebo comparator	TMD placebo group. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Surface electromiography of cranial muscles (sEMG)
Evaluation of surface electromiography of cranial muscles (expressed in microvolts)
Measured: Average of 1 year
Mandibular kinesiography (KNG)
Evaluation of mandibular kinetics (expressed in millimeters/seconds)
Measured: Average of 1 year

Secondary outcomes (1)

Pain scale
Evaluation of subjective pain perception by Visual Analog Scale (expressed in unit)
Measured: 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 201631 Dec 2020

First posted27 Oct 2016 (estimated)
Study startOct 2016
Primary completionJul 2018
Study completion31 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for TMDStudies 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
Model description: Testing Bite device "A"
Masking: Triple blind
Who is masked: Care provider, Investigator, Outcomes assessor
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02946645
Sponsor's protocol ID: 16137/24.05.2016
Acronym: BENEFIT
Status last verified: Apr 2021
First submitted: 24 Oct 2016
Last updated: 28 Apr 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

de Toledo EG Jr, Silva DP, de Toledo JA, Salgado IO. The interrelationship between dentistry and physiotherapy in the treatment of temporomandibular disorders. J Contemp Dent Pract. 2012 Sep 1;13(5):579-83.
PubMed 23250156
List T, Axelsson S. Management of TMD: evidence from systematic reviews and meta-analyses. J Oral Rehabil. 2010 May;37(6):430-51. doi: 10.1111/j.1365-2842.2010.02089.x. Epub 2010 Apr 20.
PubMed 20438615
Molin C. From bite to mind: TMD--a personal and literature review. Int J Prosthodont. 1999 May-Jun;12(3):279-88.
PubMed 10635197
Michelotti A, de Wijer A, Steenks M, Farella M. Home-exercise regimes for the management of non-specific temporomandibular disorders. J Oral Rehabil. 2005 Nov;32(11):779-85. doi: 10.1111/j.1365-2842.2005.01513.x.
PubMed 16202040
Capellini VK, de Souza GS, de Faria CR. Massage therapy in the management of myogenic TMD: a pilot study. J Appl Oral Sci. 2006 Jan;14(1):21-6. doi: 10.1590/s1678-77572006000100005.
PubMed 19089025
Ash MM Jr, Ramfjord SP. Reflections on the Michigan splint and other intraocclusal devices. J Mich Dent Assoc. 1998 Oct;80(8):32-5, 41-6.
PubMed 9863432
Yamashita A, Kondo Y, Yamashita J. Thirty-year follow-up of a TMD case treated based on the neuromuscular concept. Cranio. 2014 Jul;32(3):224-34. doi: 10.1179/0886963413Z.00000000020. Epub 2014 Jan 24.
PubMed 25000166
Di Fabio RP. Physical therapy for patients with TMD: a descriptive study of treatment, disability, and health status. J Orofac Pain. 1998 Spring;12(2):124-35.
PubMed 9656890
Starnes LO. A bite orthotic for the resting period between two phases of treatment. J Clin Orthod. 2002 Feb;36(2):92-4. No abstract available.
PubMed 11902010
Heit T. Neuromuscular orthotics in the treatment of craniomandibular dysfunction and the effects on patients with multiple sclerosis: a pilot study. Cranio. 2011 Jan;29(1):57-70. doi: 10.1179/crn.2011.009.
PubMed 21370770
Cooper BC, Kleinberg I. Establishment of a temporomandibular physiological state with neuromuscular orthosis treatment affects reduction of TMD symptoms in 313 patients. Cranio. 2008 Apr;26(2):104-17. doi: 10.1179/crn.2008.015.
PubMed 18468270
Pietropaoli D, Cooper BC, Ortu E, Monaco A; I.A.P.N.O.R.. A Device Improves Signs and Symptoms of TMD. Pain Res Manag. 2019 May 6;2019:5646143. doi: 10.1155/2019/5646143. eCollection 2019.
PubMed 31198477

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All TMD trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficiency of Neuromuscular Bite vs Physiotherapy in TMD Patients BENEFIT Study
ClinicalTrials.gov ID: NCT02946645
Acronym / sponsor ID: BENEFIT / 16137/24.05.2016
Conditions: TMD
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: University of L'AquilaUniversity, hospital or other
Study start: Oct 2016 (actual)
Primary completion: Jul 2018 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 27 Oct 2016 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: Testing Bite device "A"

Arm	Type	Receives
Manual Physiotherapy	Active comparator	Procedure: Mandibular PhysiotherapyTMD patients will treat with orofacial physiotherapy by one expert operator according to literature
Neuromuscular Bite	Active comparator	Device: Neuromuscular Bite (orthotic/sub-lingual)TMD patients will receive an intraoral neuromuscular bite according to literature
Placebo	Placebo comparator	Other: PlaceboTMD placebo group.

Who may qualify

Ages: 25 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

myogenous TMD;
pain duration longer than 3 months;
presence of complete permanent dentition, with the possible exception of the third molars;
normal occlusion.

Key exclusion criteria (14 listed)

presence of systemic or metabolic diseases;
eye diseases or visual defects;
history of local or general trauma;
neurological or psychiatric disorders;
muscular diseases;

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
Neuromuscular Bite (orthotic/sub-lingual)Bite is a device which simulates a set of properly positioned teeth	Device	Neuromuscular Bite
Mandibular PhysiotherapyMandibular Stabilisation Exercises 1. Place knuckle of index finger between top and bottom teeth. 2. Remove it, keeping the teeth separated one-knuckle apart. 3. Apply gentle pressure to the to the jaw using your index finger/thumb as demonstrated in the pictures above.	Procedure or surgery	Manual Physiotherapy
PlaceboNo interventions.	Other	Placebo

Primary outcome

Surface electromiography of cranial muscles (sEMG)
Time frame: Average of 1 year
Evaluation of surface electromiography of cranial muscles (expressed in microvolts)
Mandibular kinesiography (KNG)
Time frame: Average of 1 year
Evaluation of mandibular kinetics (expressed in millimeters/seconds)

1 secondary outcome

Pain scale
Time frame: 15 days

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 28 Apr 2021.
Background: PubMed 23250156de Toledo EG Jr, Silva DP, de Toledo JA, Salgado IO. The interrelationship between dentistry and physiotherapy in the treatment of temporomandibular disorders. J Contemp Dent Pract. 2012 Sep 1;13(5):579-83.
Background: PubMed 20438615List T, Axelsson S. Management of TMD: evidence from systematic reviews and meta-analyses. J Oral Rehabil. 2010 May;37(6):430-51. doi: 10.1111/j.1365-2842.2010.02089.x. Epub 2010 Apr 20.
Background: PubMed 10635197Molin C. From bite to mind: TMD--a personal and literature review. Int J Prosthodont. 1999 May-Jun;12(3):279-88.
Background: PubMed 16202040Michelotti A, de Wijer A, Steenks M, Farella M. Home-exercise regimes for the management of non-specific temporomandibular disorders. J Oral Rehabil. 2005 Nov;32(11):779-85. doi: 10.1111/j.1365-2842.2005.01513.x.
Background: PubMed 19089025Capellini VK, de Souza GS, de Faria CR. Massage therapy in the management of myogenic TMD: a pilot study. J Appl Oral Sci. 2006 Jan;14(1):21-6. doi: 10.1590/s1678-77572006000100005.
Background: PubMed 9863432Ash MM Jr, Ramfjord SP. Reflections on the Michigan splint and other intraocclusal devices. J Mich Dent Assoc. 1998 Oct;80(8):32-5, 41-6.
Background: PubMed 25000166Yamashita A, Kondo Y, Yamashita J. Thirty-year follow-up of a TMD case treated based on the neuromuscular concept. Cranio. 2014 Jul;32(3):224-34. doi: 10.1179/0886963413Z.00000000020. Epub 2014 Jan 24.
Background: PubMed 9656890Di Fabio RP. Physical therapy for patients with TMD: a descriptive study of treatment, disability, and health status. J Orofac Pain. 1998 Spring;12(2):124-35.
Background: PubMed 11902010Starnes LO. A bite orthotic for the resting period between two phases of treatment. J Clin Orthod. 2002 Feb;36(2):92-4. No abstract available.
Background: PubMed 21370770Heit T. Neuromuscular orthotics in the treatment of craniomandibular dysfunction and the effects on patients with multiple sclerosis: a pilot study. Cranio. 2011 Jan;29(1):57-70. doi: 10.1179/crn.2011.009.
Background: PubMed 18468270Cooper BC, Kleinberg I. Establishment of a temporomandibular physiological state with neuromuscular orthosis treatment affects reduction of TMD symptoms in 313 patients. Cranio. 2008 Apr;26(2):104-17. doi: 10.1179/crn.2008.015.
Results publication: PubMed 31198477Pietropaoli D, Cooper BC, Ortu E, Monaco A; I.A.P.N.O.R.. A Device Improves Signs and Symptoms of TMD. Pain Res Manag. 2019 May 6;2019:5646143. doi: 10.1155/2019/5646143. eCollection 2019.
Individual participant dataSharing planned: No

Related trials for TMD

Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
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Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
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Recruiting
R01_Pilot Jaw Muscle Phenotypes
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Neuromuscular Bite (orthotic/sub-lingual) and Mandibular Physiotherapy in people with TMD, run by University of L'Aquila 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 4 inclusion and 14 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 28 Apr 2021. 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. Some participants in this study may receive a placebo. 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?

Surface electromiography of cranial muscles (sEMG) (time frame: Average of 1 year). The study lists 2 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 NCT02946645, which also lists 12 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 28 Apr 2021.