Stimulation of the Proprioceptive Trigeminocardiac Reflex (PTCRSTIM)

Azienda USL 12 Versilia

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Temporomandibular Joint Disorders

Treatments: Device: Spring device; Device: Mandible stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT02908568

ISTITUTO STOMATOLOGICO TOSCANO

Details and patient eligibility

About

Study over muscular stretching to reduce pain the oral cavity.

Full description

It is a current opinion that muscular stretching is able to reduce pain and to allow increase of the opening excursion at the joints. To investigate this possibility in the face, the investigators developed a method of stretching associated with large dynamic jaws during chewing using a special device (Spring Device ®) for ten minutes, allowing the muscles of the oral cavity to relax. The height of the bite was set as two-thirds of the maximum opening (max. 2 cm.) of the mouth at rest (without forcing) thus avoiding maintaining the head of the condyle at maximum aperture for a long time. The subjects were then analyzed by means of kinesiography to determine the changes in the vertical dimension. Increasing stretching produces neuromuscular relaxation and a reduction of pain. This study showed that this therapy induces oral and extraoral pain reduction and increases neck mobility and mouth opening. The stimulation of trigeminal receptors is an important drive for therapy in the trigeminocardiac reflex (TCR).

Enrollment: 36 estimated patients

Sex: All

Ages: 8+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All the subjets up to seventy years

Exclusion criteria

• Subjects under eight years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Spring device

Experimental group

Description:

Brisk dilatation of fhe mouth.

Treatment:

Device: Spring device

Mandible stimulator

Sham Comparator group

Description:

Stimulation of fhe mouth.

Treatment:

Device: Mandible stimulator