Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-02-23 @ 8:56 PM
Study NCT ID:
NCT04059432
Status:
UNKNOWN
Last Update Posted:
2019-08-21
First Post:
2019-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CHAIN1 : Dental Wear and Musculoskeletal Disorders - Association?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057085', 'term': 'Tooth Wear'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 385}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-19', 'studyFirstSubmitDate': '2019-08-09', 'studyFirstSubmitQcDate': '2019-08-15', 'lastUpdatePostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of musculoskeletal disorders (MSDs)', 'timeFrame': 'through study completion, an average of 1 year', 'description': '"Nordique Questionnaire": validated self-report questionnaire to evaluate musculo skeletal health, particularly MSD on 9 different zones'}, {'measure': 'Tooth wear following BEWE index', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Clinical examination will give a global score on 18 following Basic Erosive Wear Examination (BEWE) index.'}], 'secondaryOutcomes': [{'measure': 'Life habits and stress', 'timeFrame': 'through study completion, an average of 1 year', 'description': '10-points likert scale self-report questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tooth Wear', 'Musculoskeletal Disorders'], 'conditions': ['Tooth Wear', 'Musculoskeletal Disorder']}, 'descriptionModule': {'briefSummary': 'This study aims to explore the relationships between tooth wear (TW) and musculoskeletal disorders (MSDs). The null hypothesis is that TW is not associated to MSDs. It also explores the influence of bruxism signs, life habits and stress on TW and MSDs.', 'detailedDescription': 'This study is based on questionnaires and clinical examination performed by a dentist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients consulting in the Fixed Prosthesis Department (Dentistry Department) at the Polyclinic Lucien Brull from Liège University Hospital between March 2019 and October 2019', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18 and 80 years old\n* Have the mental abilities to participate in study\n* Understand the language of the survey (French)\n* Sign free and informed consent\n\nExclusion Criteria:\n\n* Consult for a painful dental emergency\n* Do not have at least 8 teeth per maxilla, with natural dental tissues in contact with the antagonistic teeth\n* Being in the process of an orthodontic treatment\n* Wear of a bimaxillary orthognathic nightguard'}, 'identificationModule': {'nctId': 'NCT04059432', 'briefTitle': 'CHAIN1 : Dental Wear and Musculoskeletal Disorders - Association?', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'CHAIN1 : Dental Wear and Musculoskeletal Disorders - Association?', 'orgStudyIdInfo': {'id': 'CH001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tooth Wear and Musculoskeletal Disorders evaluation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Evaluation of dental wear by BEWE (Basic Erosive Wear Examination: score 0-3) examination and Musculoskeletal disorders are listed by the "NORDIC" questionnaire developed by Kuorinka et al. (2001)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4020', 'city': 'Liège', 'state': 'Choose A State', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Amélie Mainjot', 'role': 'CONTACT', 'email': 'a.mainjot@chuliege.be', 'phone': '+32 496 95 30 30'}], 'facility': 'Institute of Dentistry University of Liege', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'centralContacts': [{'name': 'Amélie Mainjot, DDS, MSc, PhD', 'role': 'CONTACT', 'email': 'a.mainjot@chuliege.be', 'phone': '+32 496 95 30 30'}, {'name': 'Sandrine Bekaert', 'role': 'CONTACT', 'email': 'sandrine.bekaert@chuliege.be'}], 'overallOfficials': [{'name': 'Amélie Mainjot', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHU-ULg'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': 'Include some patients in a second study to be developed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS, MSc, PhD', 'investigatorFullName': 'Mainjot Amélie', 'investigatorAffiliation': 'University of Liege'}}}}