Stimulation of the Proprioceptive Trigeminocardiac Reflex

NCT ID: NCT02908568

Last Updated: 2016-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-08-31

Brief Summary

Study over muscular stretching to reduce pain the oral cavity.

Detailed 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).

Conditions

Temporomandibular Joint Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Spring device

Brisk dilatation of fhe mouth.

Group Type: EXPERIMENTAL

Spring device

Intervention Type: DEVICE

Brisk dilatation of fhe mouth.

Mandible stimulator

Stimulation of fhe mouth.

Group Type: SHAM_COMPARATOR

Mandible stimulator

Intervention Type: DEVICE

Stimulation of fhe mouth.

Interventions

Spring device

Brisk dilatation of fhe mouth.

Intervention Type: DEVICE

Mandible stimulator

Stimulation of fhe mouth.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All the subjets up to seventy years

Exclusion Criteria

• Subjects under eight years

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Azienda USL 12 Versilia

OTHER

Sponsor Role: lead

Responsible Party

PROF. UGO COVANI

Azienda USL 12 Versilia

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Tonlorenzi D, Brunelli M, Conti M, Covani U, Traina G. An observational study of the effects of using an high oral splint on pain control. Arch Ital Biol. 2019 Sep 30;157(2-3):66-75. doi: 10.12871/00039829201923.

Reference Type: DERIVED

PMID: 31821530 (View on PubMed)

Other Identifiers

ISTITUTO STOMATOLOGICO TOSCANO

Identifier Type: -

Identifier Source: org_study_id