- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02908568
Stimulation of the Proprioceptive Trigeminocardiac Reflex (PTCRSTIM)
Effect of Stimulation of the Proprioceptive Trigeminocardiac Reflex Through Medical Device for the Pain of Patients With Temporomandibular Disorders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All the subjets up to seventy years
Exclusion Criteria:
- Subjects under eight years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Spring device
Brisk dilatation of fhe mouth.
|
Brisk dilatation of fhe mouth.
|
Sham Comparator: Mandible stimulator
Stimulation of fhe mouth.
|
Stimulation of fhe mouth.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mandibular stretching influences the temporomandibular disorders
Time Frame: up to 24 weeks
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mandibular stretching induces a reduction of facial contraction and decrease of heart rate
Time Frame: up to 24 weeks
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISTITUTO STOMATOLOGICO TOSCANO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Hacettepe UniversityThe Scientific and Technological Research Council of TurkeyRecruitingTemporomandibular Joint Disorders | Temporomandibular Joint Dysfunction Syndrome | Temporomandibular Disorder | Temporomandibular Joint Pain | Manual Therapy | Temporomandibular Joint Disc DisplacementTurkey
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Karolinska InstitutetUniversity of Oslo; University of BergenCompletedTemporomandibular Joint Disorders | Temporomandibular Joint Disc Displacement | Temporomandibular Joint Osteoarthritis | Temporomandibular ArthritisSweden
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Hacettepe UniversityKarabuk UniversityRecruitingTemporomandibular Joint Disorders | Temporomandibular Joint Dysfunction Syndrome | Temporomandibular DisorderTurkey
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CES UniversityCompletedTemporomandibular Disorder | Children, Only | Pain Disorder | Joint Disorder, Temporomandibular
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