Stimulation of the Proprioceptive Trigeminocardiac Reflex

Temporomandibular Joint Disorders Clinical Trial

— PTCRSTIM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02908568
• Other study ID #: ISTITUTO STOMATOLOGICO TOSCANO
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: September 7, 2016
• Last updated: September 21, 2016
• Start date: September 2016
• Est. completion date: August 2017

Study information

• Verified date: September 2016
• Source: Azienda USL 12 Versilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Study over muscular stretching to reduce pain the oral cavity.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• All the subjets up to seventy years

Exclusion Criteria:

• Subjects under eight years

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Device:
• Spring device
Brisk dilatation of fhe mouth.
• Mandible stimulator
Stimulation of fhe mouth.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda USL 12 Versilia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mandibular stretching influences the temporomandibular disorders	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.	up to 24 weeks	Yes
Secondary	mandibular stretching induces a reduction of facial contraction and decrease of heart rate	Those 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.	up to 24 weeks	Yes