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Stimulation of the Proprioceptive Trigeminocardiac Reflex

Effect of Stimulation of the Proprioceptive Trigeminocardiac Reflex Through Medical Device for the Pain of Patients With Temporomandibular Disorders

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02908568
Acronym
PTCRSTIM
Enrollment
36
Registered
2016-09-21
Start date
2016-09-30
Completion date
2017-08-31
Last updated
2016-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Joint Disorders

Keywords

mandibular stretching, trigeminocardiac reflex

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).

Interventions

DEVICESpring device

Brisk dilatation of fhe mouth.

DEVICEMandible stimulator

Stimulation of fhe mouth.

Sponsors

Azienda USL 12 Versilia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* All the subjets up to seventy years

Exclusion criteria

* Subjects under eight years

Design outcomes

Primary

MeasureTime frameDescription
Mandibular stretching influences the temporomandibular disordersup to 24 weeksIt 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.

Secondary

MeasureTime frameDescription
mandibular stretching induces a reduction of facial contraction and decrease of heart rateup to 24 weeksThose effects are described as trigemino-cardiac reflex. Application of a spring device (which consists of thin sheet of surgical steel bent in to a loop) induces a decrease of blood pressure and heart rate.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026