Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT06787261
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-22
First Post:
2025-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Involvement of Archaea in Carious Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2025-01-16', 'studyFirstSubmitQcDate': '2025-01-16', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Presence/absence of Archaea in participants' saliva samples.", 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': 'Quantity of Archaea in the salivary sample of the participants.', 'timeFrame': '36 months'}, {'measure': 'Viability/non-viability of Archaea in carious lesions', 'timeFrame': '36 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental caries'], 'conditions': ['Dental Caries']}, 'descriptionModule': {'briefSummary': 'Dental caries is a major public health probleme the result of hard tissue demineralization and oral microbiota changes.\n\nMethanogenic archaea, mainly Methanobrevibacter oralis, are associated with various oral problems, including pathologies periodontal.\n\nPrevious research has not really studied the Archaea in carious lesions, hence the importance of our study.\n\nOur study aims to explore their potential role in the the development of caries by analysing their prevalence and their quantification in relation to the carious risk individual. The aim is to improve understanding of the Cavity microbiology to advance management of this pathology in terms of prevention or of treatment.\n\nOur team is particularly competent in the field of Archaea, especially in the cultivation of Archaea methanogens since we have a dedicated platform. We also discovered the first human Nanoarchaea, opening up a whole new possible search field.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female of legal age.\n* Patient who is a beneficiary or entitled beneficiary of a social security\n* Patient under the care of the Restorative and Preventive Dentistry of the PROMOD - Timone Dentistry Unit.\n* Patients capable of giving written consent.\n\nExclusion Criteria:\n\nPatient in a period of exclusion from another research protocol at the time of signing the consent form, Subjects covered by articles L1121-5 to 1121-8 of the Public Health public health code (minor patients, patients of full age under guardianship, patients deprived of their liberty, pregnant or breast-feeding), A person who does not have a sufficient command of reading and understanding of the French language to be able to consent to take part in the research Presence of periodontitis (gingivitis not being a criterion for a criterion for non-inclusion). Antibiotics taken in the previous month. Use of mouthwash in the previous 7 days.'}, 'identificationModule': {'nctId': 'NCT06787261', 'acronym': 'CARIARCHAE', 'briefTitle': 'Involvement of Archaea in Carious Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Involvement of Archaea in Carious Disease', 'orgStudyIdInfo': {'id': 'RCAPHM24-0329'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low risk of carriages', 'interventionNames': ['Other: saliva sample']}, {'type': 'OTHER', 'label': 'high risk for caries.', 'interventionNames': ['Other: saliva sample', 'Other: carious tissue samples']}], 'interventions': [{'name': 'saliva sample', 'type': 'OTHER', 'description': 'saliva sample', 'armGroupLabels': ['high risk for caries.', 'low risk of carriages']}, {'name': 'carious tissue samples', 'type': 'OTHER', 'description': 'carious tissue samples', 'armGroupLabels': ['high risk for caries.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'country': 'France', 'contacts': [{'name': 'PILLIOL Virginie investigator', 'role': 'CONTACT', 'email': 'virginie.pilliol@ap-hm.fr'}], 'facility': 'Asssistance Publique Hopitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Giuliani alexandra project manager', 'role': 'CONTACT', 'email': 'alexandra.giuliani@ap-hm.fr', 'phone': '+33491382747'}], 'overallOfficials': [{'name': 'jean-olivier ARNAUD GENERAL DIRECTOR', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hopitaux De Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}