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Randomized Controlled Trial
. 2019 May 6:2019:5646143.
doi: 10.1155/2019/5646143. eCollection 2019.

A Device Improves Signs and Symptoms of TMD

Affiliations
Randomized Controlled Trial

A Device Improves Signs and Symptoms of TMD

Davide Pietropaoli et al. Pain Res Manag. .

Erratum in

Abstract

Background: Temporomandibular joint dysfunction (TMD) therapy remains an open challenge for modern dentistry. Herein, we propose a new neuromuscular lingual device able to reduce signs and symptoms of TMD in female patients with chronic orofacial pain.

Methods: 50 females with myofascial TMD according to RDC/TMD were randomly assigned to study (n = 25) and control groups (n = 25). At T0, both groups received sEMG/KNG and pain evaluation by the VAS scale. The study group received the ELIBA device (lingual elevator by Balercia) constructed under ULF-TENS (ultra-low-frequency transcoutaneous electrical nervous stimulation). Subjects were instructed to use ELIBA at least for 16 h/day. After 6 months (T1), both groups underwent to sEMG/KNG and VAS revaluation.

Results: T1 study group compared to controls showed a significant reduction in total (p < 0.0001) and mean (p < 0.0001) sEMG values, as well as a significant increase in both maximum vertical mouth opening (p=0.003) and maximum velocity in mouth opening (p=0.003) and closing (p < 0.0001). Interestingly, a significant reduction in pain measured by VAS (p < 0.0001) was reported.

Conclusions: After 6 months, the ELIBA device is able to significantly reduce TMD-associated myogenous pain and to promote the enhancement of sEMG/KNG values.

Practical implications: ELIBA can be considered as a new device, potentially useful for head-neck pain relief in patients suffering from chronic TMD. In addition, its use promotes a muscles relaxation inducing freeway space increase. This characteristic makes it particularly useful for rehabilitation of patients with not enough space for construction of conventional orthotics or neuromuscular bites.

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Conflict of interest statement

IAPNOR holds a registered patent on the ELIBA® device, c/o the Italian Ministry of Economic Development, patent office.

Figures

Figure 1
Figure 1
ELIBA construction phases and oral aspect of the device. (a) Marking of the lateral/distal borders of the ELIBA® device, as specified by the clinician. (b) Detail of the caudal part of the acrylic impression. (c) The ELIBA® appliance on the plastic cast and impression of the ELIBA® device, as finished in the dental laboratory following the instructions of the clinician. (d) Enlargement of the device ELIBA® applied on the plastic cast with hooks in front area in cobalt chrome. (e-h) Intraoral views of the ELIBA appliance fitted to the oral cavity of the patient. (f) The ELIBA® device without occlusal contacts. (g) ELIBA® on plastic cast with connection arm hook joined with weld.

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