Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-03-01 @ 4:14 PM
Study NCT ID:
NCT02908568
Status:
UNKNOWN
Last Update Posted:
2016-09-22
First Post:
2016-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stimulation of the Proprioceptive Trigeminocardiac Reflex
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-21', 'studyFirstSubmitDate': '2016-09-07', 'studyFirstSubmitQcDate': '2016-09-17', 'lastUpdatePostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mandibular stretching influences the temporomandibular disorders', 'timeFrame': 'up to 24 weeks', '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.\n\nTo 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.'}], 'secondaryOutcomes': [{'measure': 'mandibular stretching induces a reduction of facial contraction and decrease of heart rate', 'timeFrame': 'up to 24 weeks', '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['mandibular stretching, trigeminocardiac reflex'], 'conditions': ['Temporomandibular Joint Disorders']}, 'referencesModule': {'references': [{'pmid': '31821530', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'Study over muscular stretching to reduce pain the oral cavity.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All the subjets up to seventy years\n\nExclusion Criteria:\n\n* Subjects under eight years'}, 'identificationModule': {'nctId': 'NCT02908568', 'acronym': 'PTCRSTIM', 'briefTitle': 'Stimulation of the Proprioceptive Trigeminocardiac Reflex', 'organization': {'class': 'OTHER', 'fullName': 'Azienda USL 12 Versilia'}, 'officialTitle': 'Effect of Stimulation of the Proprioceptive Trigeminocardiac Reflex Through Medical Device for the Pain of Patients With Temporomandibular Disorders', 'orgStudyIdInfo': {'id': 'ISTITUTO STOMATOLOGICO TOSCANO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spring device', 'description': 'Brisk dilatation of fhe mouth.', 'interventionNames': ['Device: Spring device']}, {'type': 'SHAM_COMPARATOR', 'label': 'Mandible stimulator', 'description': 'Stimulation of fhe mouth.', 'interventionNames': ['Device: Mandible stimulator']}], 'interventions': [{'name': 'Spring device', 'type': 'DEVICE', 'description': 'Brisk dilatation of fhe mouth.', 'armGroupLabels': ['Spring device']}, {'name': 'Mandible stimulator', 'type': 'DEVICE', 'description': 'Stimulation of fhe mouth.', 'armGroupLabels': ['Mandible stimulator']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda USL 12 Versilia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Azienda USL 12 Versilia', 'investigatorFullName': 'PROF. UGO COVANI', 'investigatorAffiliation': 'Azienda USL 12 Versilia'}}}}