Efficiency of Neuromuscular Bite vs Physiotherapy in TMD Patients

TMD Clinical Trial

— BENEFIT  

Official title:

Efficiency of Neuromuscular Bite vs Physiotherapy in TMD Patients BENEFIT Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946645
• Other study ID #: 16137/24.05.2016
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2021
• Source: University of L'Aquila
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. To our knowledge, no specific trials have been designed for the evaluation of the efficiency of physiotherapy vs neuromuscular bites in TMD patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 31, 2020
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• myogenous TMD;

• pain duration longer than 3 months;

• presence of complete permanent dentition, with the possible exception of the third molars;

• normal occlusion.

Exclusion Criteria:

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;

• 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

Related Conditions & MeSH terms

• TMD

Intervention

Device:
• Neuromuscular Bite (orthotic/sub-lingual)
Bite is a device which simulates a set of properly positioned teeth

Procedure:
• Mandibular Physiotherapy
Mandibular Stabilisation Exercises Place knuckle of index finger between top and bottom teeth. Remove it, keeping the teeth separated one-knuckle apart. Apply gentle pressure to the to the jaw using your index finger/thumb as demonstrated in the pictures above.

Other:
• Placebo
No interventions.

Locations

Country	Name	City	State
Italy	Dental Clinic, University of L'Aquila, St. Salvatore Hospital,	L'Aquila

Sponsors (1)

Lead Sponsor	Collaborator
University of L'Aquila

Country where clinical trial is conducted

Italy, 

References & Publications (12)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Molin C. From bite to mind: TMD--a personal and literature review. Int J Prosthodont. 1999 May-Jun;12(3):279-88. Review. — View Citation

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. Erratum in: Pain Res Manag. 2020 Apr 17;2020:9465080. — View Citation

Starnes LO. A bite orthotic for the resting period between two phases of treatment. J Clin Orthod. 2002 Feb;36(2):92-4. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surface electromiography of cranial muscles (sEMG)	Evaluation of surface electromiography of cranial muscles (expressed in microvolts)	Average of 1 year
Primary	Mandibular kinesiography (KNG)	Evaluation of mandibular kinetics (expressed in millimeters/seconds)	Average of 1 year
Secondary	Pain scale	Evaluation of subjective pain perception by Visual Analog Scale (expressed in unit)	15 days