Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-02-23 @ 12:22 AM
Study NCT ID:
NCT05079204
Status:
COMPLETED
Last Update Posted:
2025-04-03
First Post:
2021-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoral Scanners as a Motivation Method for Oral Hygiene Instruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'The investigator which perform the periodontal examination will be blinded of the motivation procedure'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2021-10-05', 'studyFirstSubmitQcDate': '2021-10-05', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plaque Control Record Evolution', 'timeFrame': 'Day 14', 'description': 'Recording the presence of plaque on individual tooth surfaces (mesial, distal, facial, lingual). The plaque is highlighted by a periodontal probe.\n\nPCR is calculated according the following formula :\n\nPCR = (Number of faces with plaque / Total number of faces) x 100'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontitis', 'Gingivitis']}, 'descriptionModule': {'briefSummary': "Periodontal diseases are highly prevalent inflammatory diseases. These diseases are mostly due to the development and the maturation of bacterial plaque which lead to local inflammation. Individuals can develop severe attachment loss which could lead to dental loss. To prevent them, individual plaque removal procedures self-performed by the patient by tooth brushing or interdental brushes or made by professional care (scaling), are known to improve periodontal health, and thus to prevent periodontal diseases. Moreover, oral hygiene is a major factor to increase increasing the outcomes when treatments are needed. However, patients' compliance in oral health program is one of the major limits to periodontal therapeutics.\n\nIn this study, the investigators evaluate the effectiveness of 3D intra-oral camera compared with conventional oral hygiene instructions, to improve oral health motivation.", 'detailedDescription': "The present study explores the effectiveness of intraoral scanners in the field of oral hygiene motivation and instruction to improve the patient's motivation.\n\nPatients presenting periodontitis or gingivitis are recruited and randomized in 2 groups: conventional motivation procedures and conventional motivation procedures supported with 3D representations of their mouth obtained by intraoral scanners. Periodontal diseases (periodontitis and gingivitis) will be diagnosed according to the international classification of periodontal diseases, based on the decision-making algorithms. A periodontal charting, socio-demographic data and clinical data will be collected. Then, oral mucosa dermatological manifestations, treatment needs (ICDAS) and quality of life related to oral health (GOHAI) will be evaluated.\n\nAfter inclusion, patients will be randomized between conventional motivation procedures and conventional motivation procedures associated with 3D intra oral procedures.\n\nThe investigators hypothesized that the 3D intra oral representations could improve oral hygiene in patients compared with those receiving only a classical motivation procedure. The primary objective is to evaluate if patients instructed to oral hygiene procedures using a representation of their mouth obtained by the use of a intraoral scanner present fewer plaque than the ones instructed without it. This could be achieved by the analysis of plaque control record index in both group.\n\nThe secondary objectives are :\n\n* To compare the evolution of the bleeding on probing clinical index between the two groups.\n* To compare the evolution of mean periodontal pocket depths, mean recessions and mean clinical attachment level between the two groups.\n* To compare the quality of life related to oral health between the two groups\n* To evaluate the time needed to add intraoral scans in the procedure\n* To evaluate the relevance of the received information."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients\n\n* consulting the Dental Care Service of the university hospital of Reims\n* presenting gingivitis or periodontal diseases according to the international classification of periodontal diseases (Chicago, 2017)\n* presenting at least 10 pairs of opposing teeth\n* able to perform oral hygiene procedures\n* speaking French\n* who signed the informed consent form\n* affiliated to the French Social Security system\n\nNon-inclusion criteria :\n\nPatients presenting :\n\n* a medical history likely to compromise protocol (psychiatric disorders, medical or pharmacological antecedents altering or modifying immune response in last 3 months)\n* pregnancy or breastfeeding\n* eating disorders\n* orthodontic treatments\n* patients under legal protection, trusteeship or guardianship\n* unable to understand auto-questionary\n\nExclusion criteria :\n\nPatients presenting :\n\n* presenting exacerbations signs of periodontal diseases\n* benefiting a professional plaque removal procedure outside of the experimental procedure'}, 'identificationModule': {'nctId': 'NCT05079204', 'acronym': 'Perio3D', 'briefTitle': 'Intraoral Scanners as a Motivation Method for Oral Hygiene Instruction', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Reims'}, 'officialTitle': 'Effectiveness of Intraoral Scanners as a Motivation Method for Oral Hygiene Instruction', 'orgStudyIdInfo': {'id': 'PO20159*'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional motivation procedure', 'description': "Conventional motivation procedures defined as a presentation of the modified Bass technique on a dental teaching macro model plus intra oral instruction provided in patient's mouth with a hand mirror.", 'interventionNames': ['Other: No intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional motivation procedure supported by 3D representations', 'description': 'Conventional motivation procedures associated with 3D intra oral procedures. A 3D intra-oral modelization will added to the previously described procedure. Then, a periodontist will show the sites contaminated by dental plaque to the patient.', 'interventionNames': ['Other: Intra oral scan']}], 'interventions': [{'name': 'Intra oral scan', 'type': 'OTHER', 'otherNames': ['Conventional motivation procedures supported by 3D representations'], 'description': 'Cover key details of the intervention. Must be sufficiently detailed to distinguish between arms of a study and/or among similar interventions Intervention consists in an 3D intra oral representation of the oral cavity.', 'armGroupLabels': ['Conventional motivation procedure supported by 3D representations']}, {'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Conventional motivation procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'Chu Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Reims', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}