Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-31 @ 4:01 PM
Study NCT ID:
NCT03139994
Status:
COMPLETED
Last Update Posted:
2021-10-01
First Post:
2016-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Altered MAstication Contribute to TMJ PAin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}, {'id': 'D001733', 'term': 'Bites and Stings'}, {'id': 'D010146', 'term': 'Pain'}], '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'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-30', 'studyFirstSubmitDate': '2016-05-10', 'studyFirstSubmitQcDate': '2017-05-01', 'lastUpdatePostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hemimandibular retrognathia', 'timeFrame': 'Baseline', 'description': 'Interincisal median midline and Angle Class on each side'}, {'measure': 'Hemispheric dominance, asuming oposite side to handedness preference', 'timeFrame': 'Baseline', 'description': 'Edinburg inventory (Oldfield)'}, {'measure': 'Change of Life quality', 'timeFrame': 'Baseline, 3 years follow-up', 'description': 'SCL-90-R self-administered questionaire'}], 'primaryOutcomes': [{'measure': 'Presence or not of symptoms of temporomandibular joint disorders according to DC/TMD', 'timeFrame': 'At 3 years follow-up', 'description': 'Pain-intensity (0-10 VAS scale, Von Korf)'}, {'measure': 'Change of maximal unassited jaw opening', 'timeFrame': 'Baseline and 3 years follow-up', 'description': 'Maximum unassisted jaw opening or interincisal distance (from edge to edge) measured by a Boley gauge. Up 38 in females and up 40 mm in males are considered limited.'}], 'secondaryOutcomes': [{'measure': 'Change of condylar paths angles inclination', 'timeFrame': 'Baseline and 3-4-years follow-up (end of the study)', 'description': 'Alteration of parasagittal plane Axiography of condyle motion in respect Frankfort horizontal plane'}, {'measure': 'Alteration of lateral dental guidance angles', 'timeFrame': 'Baseline and 4-years follow-up (end of the study)', 'description': 'Angle between Frankfort plane and lateral dental anterior guidance'}, {'measure': 'Change of maximal comfortable jaw opening', 'timeFrame': 'Baseline and 4-years follow-up (end of the study)', 'description': 'Maximum jaw opening or interincisal distance (from edge to edge) measured by a Boley gauge. Up 38 in females and up 40 mm in males are considered limited.'}, {'measure': 'Change of the habitual chewing side', 'timeFrame': 'Baseline and 3-4-years follow-up (end of the study)', 'description': "Determining the habitual chewing side by direct observation using chewing gum, First cicle, and subsequent cicles (7 or over of 10 cicles), interview (used one habitual chewing side?: 1, no, alternate; 2, yes, right; 3, yes, left; 4, I don't know) and kinesiography."}, {'measure': 'Change of lateral deviation during maximal unassisted jaw opening', 'timeFrame': 'Baseline, 3 years follow-up', 'description': 'Kiesiography K7'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['occlusion', 'pain'], 'conditions': ['Temporomandibular Joint Disorders', 'Mastication Disorder']}, 'referencesModule': {'references': [{'pmid': '23593156', 'type': 'RESULT', 'citation': 'Santana-Mora U, Lopez-Cedrun J, Mora MJ, Otero XL, Santana-Penin U. Temporomandibular disorders: the habitual chewing side syndrome. PLoS One. 2013 Apr 8;8(4):e59980. doi: 10.1371/journal.pone.0059980. Print 2013.'}]}, 'descriptionModule': {'briefSummary': 'The cause of temporomandibular joint disorders remains unknown. It is considered multifactorial and includes physical (peripheral) and psychosocial (central) factors. It has been showed an association: a steeper condylar path, flatter lateral anterior guidance, and habitual chewing on the symptomatic side. This finding argues the possibility of causation of some of these characteristics. This double blind longitudinal study aims to assess if the presence of one habitual chewing side could contribute to temporomandibular joint disorders over time.\n\nMethod. Young adults with no signs or symptoms of TMD will be assessed. Participants with one chewing side (observed and interview); with steeper condylar path and lower lateral guidance angles will be considered consistent one side chewers, and this side will be considered more susceptible to suffer TMD. Mouth opening, hemispheric dominance and hemimandibular retrognathia will be considered as secondary pre-specified outcomes. Four years later, both TMJs of each participant presenting signs and/or symptoms will be evaluated according to DC/TMD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Medical or Dental School students. Healthy young adults with fully dentate normal occlusion', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthies\n* full dentates\n* normal occlusion\n* One habitual chewing side\n\nExclusion Criteria:\n\n* Severe malocclusion, dental decay, severe periodontal disease.\n\nPains from other origins or Orthodontics are not criteria for exclusion'}, 'identificationModule': {'nctId': 'NCT03139994', 'acronym': 'MAPA', 'briefTitle': 'Altered MAstication Contribute to TMJ PAin', 'organization': {'class': 'OTHER', 'fullName': 'University of Santiago de Compostela'}, 'officialTitle': 'One Habitual Chewing Side May Contribute to Chronic Temporomandibular Joint Disorder Pain', 'orgStudyIdInfo': {'id': '20130123'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Diagnostic', 'type': 'OTHER', 'description': 'OBSERVATIONAL, DIAGNOSTIC PROCEDURES. Young adults with no signs or symptoms of TMD will be assessed. The chewing function, condylar path angles and lateral guidance angles will be recorded. Maximum comfortable and unassisted jaw opening, hemispheric dominance and hemimandibular retrognathia will be considered as secondary pre-specified outcomes. Three-Four years later, both TMJs of each participant presenting signs and/or symptoms will be evaluated according to DC/TMD. Same recordings as baseline will be carried out.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15702', 'city': 'Santiago de Compostela', 'state': 'A Coruña', 'country': 'Spain', 'facility': 'University of Santiago de Compostela', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}], 'overallOfficials': [{'name': 'Urbano Santana-Mora, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Santiago de Compostela. Spain'}, {'name': 'Urbano Santana, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Santiago de Compostela. Spain'}, {'name': 'Mª Jesús Mora', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Santiago de Compostela. Spain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data will be shared in a on-line appendix linked from the article in a JCR Journal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Santiago de Compostela', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PROFESSOR', 'investigatorFullName': 'Urbano Santana Penin, MD, DDS, PhD', 'investigatorAffiliation': 'University of Santiago de Compostela'}}}}