Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-01-02 @ 12:18 AM
Study NCT ID:
NCT02908568
Status:
UNKNOWN
Last Update Posted:
2016-09-22
First Post:
2016-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stimulation of the Proprioceptive Trigeminocardiac Reflex
Sponsor:
Azienda USL 12 Versilia
Organization:
Study Overview
Official Title:
Effect of Stimulation of the Proprioceptive Trigeminocardiac Reflex Through Medical Device for the Pain of Patients With Temporomandibular Disorders
Status:
UNKNOWN
Status Verified Date:
2016-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PTCRSTIM
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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: