Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT05348018
Status:
COMPLETED
Last Update Posted:
2023-03-28
First Post:
2022-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Serious Games for Training in Oral Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D006266', 'term': 'Health Education'}], 'ancestors': [{'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were allocated either to a "test" group which accessed Serious games during a four-week test period in addition to conventional lectures or to a "control" group which benefited solely from conventional lectures'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-27', 'studyFirstSubmitDate': '2022-04-19', 'studyFirstSubmitQcDate': '2022-04-22', 'lastUpdatePostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'performance', 'timeFrame': 'One month', 'description': "Students' performance for managing a dental visit of edentulous patients were assessed by measuring score to a test developed by the teaching team. Scores were calculated ranging from 0 (no correct answer) to 15 (100% correct answers)."}], 'secondaryOutcomes': [{'measure': "students' satisfaction", 'timeFrame': 'one month', 'description': 'a questionnaire was drawn up for the students in the form of an self-administered questionnaire, which included questions pertaining to their satisfaction ranging from 0 (=very unsatisfactory) to 10 (=very satisfactory).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['health education'], 'conditions': ['Health Knowledge, Attitudes, Practice']}, 'descriptionModule': {'briefSummary': 'Coronavirus disease-19 (COVID-19) dramatically changed the learning conditions of dental students, with restricted access to training sessions and clinical practice. The "Playdent" project proposed the integration of serious games (SGs) in the third-year curriculum, based on tailor-made scenarios questioning the first dental visit of edentulous patients, and examined whether training with the games would advance students\' learning outcomes.', 'detailedDescription': "Three Serious games proposed in addition to conventional lectures and practical exercises in oral rehabilitation of edentulous patients were supposed to improve knowledge and skills of undergraduates. However, in order to assess the influence of SGs on students' learning outcomes and subsequent satisfaction, a single-blind controlled protocol was designed. The null hypothesis was that SGs had no impact on the learning outcomes of undergraduate students."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult students (aged at least 18)\n* enrolled in the third-year at the faculty of dental surgery of the University of Paris,\n* agreeing to participate in the study\n\nExclusion Criteria:\n\n* Third-year students who had repeated their courses'}, 'identificationModule': {'nctId': 'NCT05348018', 'acronym': 'Playdent', 'briefTitle': 'Serious Games for Training in Oral Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Rothschild'}, 'officialTitle': 'Implementation of Game-based Training in Oral Rehabilitation of Edentulous Patients in Undergraduate Dental Course', 'orgStudyIdInfo': {'id': 'PlY01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '"test" group', 'description': '"test" group which accessed SGs during a four-week test period in addition to conventional lectures', 'interventionNames': ['Device: Playing Serious Games during a four-week test period in addition to conventional lectures']}, {'type': 'NO_INTERVENTION', 'label': '"control" group', 'description': '"control" group which benefited solely from conventional lectures'}], 'interventions': [{'name': 'Playing Serious Games during a four-week test period in addition to conventional lectures', 'type': 'DEVICE', 'description': 'Playing SGs during a four-week test period in addition to conventional lectures in oral rehabilitation', 'armGroupLabels': ['"test" group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75006', 'city': 'Paris', 'state': 'Parisl', 'country': 'France', 'facility': 'Université de Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Adeline Braud, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unievrsité de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Rothschild', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr Braud Adeline', 'investigatorAffiliation': 'Hôpital Rothschild'}}}}