Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-01 @ 9:53 PM
Study NCT ID:
NCT02235220
Status:
UNKNOWN
Last Update Posted:
2014-09-26
First Post:
2014-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction of Masticatory Muscle Activity by Restoring Canine Guidance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002012', 'term': 'Bruxism'}, {'id': 'D009135', 'term': 'Muscular Diseases'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D006184', 'term': 'Habits'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-25', 'studyFirstSubmitDate': '2014-09-04', 'studyFirstSubmitQcDate': '2014-09-08', 'lastUpdatePostDateStruct': {'date': '2014-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of masticatory muscular activity', 'timeFrame': '13 weeks', 'description': 'Masticatory muscular activity is measured before and after treatment with additive composite resin fillings (Tetric EvoCeram, Ivoclar Vivadent, Schaan, Liechtenstein). A Grindcare (Medotech A/S, Herlev, Denmark) device is used for determination of muscular activity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bruxism'], 'conditions': ['Bruxism', 'Myopathy', 'Muscular Activity']}, 'descriptionModule': {'briefSummary': 'In this study it is to be evaluated wether a restoration with composite resin fillings to reestablish a canine guidance will reduce masticatory muscle activity in patients with bruxism.', 'detailedDescription': '30 patients showing clinical symptoms of bruxism receive treatment within this clinical trial. Typical symptoms like pain or tenseness of the masticatory muscles, headache or abrasions are mandatory preconditions. Exclusion criteria are a present treatment with a biteguard or a sufficient canine guidance.\n\nIn the first session a detailed history, a dental status and a clinical functional status are recorded. The baseline situation is documented by taking impressions with alginate of the maxilla and mandible for diagnostic study models. Following this procedure a first measurement of the muscular activity is conducted for seven days with the Grindcare device.\n\nAfter four weeks without any intervention a second measurement is conducted again for seven days.\n\nIn the next session the canine cusps are restored with composite fillings. Finally a sufficient canine guidance should be present. In the same session a second impression of the maxilla is taken. A third measurement is conducted, again followed by four weeks without any intervention.\n\nAt last another impression of the maxilla is obtained and a final measurement for seven days is conducted.\n\nAt the first examination and after the third measurement of the masticatory muscle activity the patients fill out the questionnaire of the Oral Health Impact Profile in order to allow for the assessment of possible functional restraints and mental interferences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients show signs of bruxism\n* no canine guidance is present\n* no prosthodontic restorations of the canine are present\n\nExclusion Criteria:\n\n* a sufficient canine guidance is present'}, 'identificationModule': {'nctId': 'NCT02235220', 'briefTitle': 'Reduction of Masticatory Muscle Activity by Restoring Canine Guidance', 'organization': {'class': 'OTHER', 'fullName': 'University of Kiel'}, 'officialTitle': 'Reduction of Masticatory Muscle Activity by Restoring Canine Guidance With Composite Resin Fillings in Patients With Bruxism.', 'orgStudyIdInfo': {'id': 'Canine guidance / Grindcare'}, 'secondaryIdInfos': [{'id': 'D 432/12', 'type': 'OTHER', 'domain': 'Ethics Commission University of Kiel, Germany'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Composite resin restoration', 'description': 'A canine guidance is reestablished by additive composite resin restorations of the canine cusp.', 'interventionNames': ['Other: Composite resin restoration']}], 'interventions': [{'name': 'Composite resin restoration', 'type': 'OTHER', 'description': 'Masticatory muscular activity is measured before and after treatment with additive composite resin fillings (Tetric EvoCeram, Ivoclar Vivadent, Schaan, Liechtenstein). A Grindcare (Medotech A/S, Herlev, Denmark) device is used for determination of muscular activity.\n\nA first measurement is conducted, followed by 4 weeks without any intervention. A second measurement is then carried out before restoration of the canine cusps with composite fillings. A third measurement is conducted, again followed by 4 weeks without any intervention. At last a final measurement is conducted.', 'armGroupLabels': ['Composite resin restoration']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Matthias Kern, DDS, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Kiel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kiel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Martin Sasse, D.M.D, Assistant Professor', 'investigatorFullName': 'Martin Sasse', 'investigatorAffiliation': 'University of Kiel'}}}}