search
Back to results

Stimulation of the Proprioceptive Trigeminocardiac Reflex (PTCRSTIM)

Primary Purpose

Temporomandibular Joint Disorders

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Spring device
Mandible stimulator
Sponsored by
Azienda USL 12 Versilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring mandibular stretching, trigeminocardiac reflex

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All the subjets up to seventy years

Exclusion Criteria:

  • Subjects under eight years

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Spring device

    Mandible stimulator

    Arm Description

    Brisk dilatation of fhe mouth.

    Stimulation of fhe mouth.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    September 7, 2016
    Last Updated
    September 21, 2016
    Sponsor
    Azienda USL 12 Versilia
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02908568
    Brief Title
    Stimulation of the Proprioceptive Trigeminocardiac Reflex
    Acronym
    PTCRSTIM
    Official Title
    Effect of Stimulation of the Proprioceptive Trigeminocardiac Reflex Through Medical Device for the Pain of Patients With Temporomandibular Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    August 2017 (Anticipated)
    Study Completion Date
    August 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Azienda USL 12 Versilia

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Temporomandibular Joint Disorders
    Keywords
    mandibular stretching, trigeminocardiac reflex

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Spring device
    Arm Type
    Experimental
    Arm Description
    Brisk dilatation of fhe mouth.
    Arm Title
    Mandible stimulator
    Arm Type
    Sham Comparator
    Arm Description
    Stimulation of fhe mouth.
    Intervention Type
    Device
    Intervention Name(s)
    Spring device
    Intervention Description
    Brisk dilatation of fhe mouth.
    Intervention Type
    Device
    Intervention Name(s)
    Mandible stimulator
    Intervention Description
    Stimulation of fhe mouth.
    Primary Outcome Measure Information:
    Title
    Mandibular stretching influences the temporomandibular disorders
    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.
    Time Frame
    up to 24 weeks
    Secondary Outcome Measure Information:
    Title
    mandibular stretching induces a reduction of facial contraction and decrease of heart rate
    Description
    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.
    Time Frame
    up to 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All the subjets up to seventy years Exclusion Criteria: Subjects under eight years

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    31821530
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Stimulation of the Proprioceptive Trigeminocardiac Reflex

    We'll reach out to this number within 24 hrs