Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-28 @ 5:20 AM
Study NCT ID:
NCT04251650
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2020-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PAROMIP Pilot Study PAROdontites & MIcrobiota Periodontal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D055113', 'term': 'Chronic Periodontitis'}, {'id': 'D064806', 'term': 'Dysbiosis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'subgingival plaque sample and gingival fluid sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-31', 'studyFirstSubmitDate': '2020-01-30', 'studyFirstSubmitQcDate': '2020-01-30', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbiota analysis of subgingival plaque', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'sample analysis by microbiome sequencing with 16S technics of subgingival plaque of affected sites and healthy sites'}], 'secondaryOutcomes': [{'measure': 'Cytokinic concentrations in CGF', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'cytokinic concentration analysis (IL1β, IL , TNFα, IL2, IL4, IL10, IL17α) in CGF of affected sites and healthy sites'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['subgingival microbiota', 'chronic periodontitis', 'dysbiosis', 'deep sequencing', 'gingival crevicular fluid'], 'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'A new classification of periodontal diseases was created in 2018. the investigators want to know if this clinical classification is based, or not, on a biological reality. To do this, the investigators will collect data from the clinical examination (clinical assessment and radiological assessment) as well as non-invasive samples of subgingival plaque and crevicular gingival fluid (CGF). The subgingival plaque samples will be analyzed to define the microbiotic profiles of the patients and the CGF determined to define their inflammatory expression profiles. These results will then be linked to the diagnosis of severity of periodontitis.', 'detailedDescription': 'In the new classification of periodontal disease, the investigators will seek to know whether there is a specific bacterial signature associated with the severity of damage on the one hand, and the other hand, the investigators will search for cytokinic biomarkers which can be correlated with the severity of the damage.\n\nIn this study, the investigators propose to include 25 patients with periodontitis stage I and II versus stage III and IV according to Chicago classification (2018)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patient coming in consultation for generalized periodontitis .', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women speaking and understanding French\n* Aged over 18\n* with generalized periodontitis (more than 30% of affected sites)\n* Requiring non-surgical periodontal therapy\n* with a minimum of 12 teeth (3 per quadrant), fitted or not\n* Having given his oral consent to participate in the study\n* Having given his written consent to participate in a biocollection\n\nExclusion Criteria:\n\n* Less than 12 teeth present (3 teeth per quadrant)\n* Presence of acute oral lesions (periodontal abscesses, endodontic abscesses, infectious or mycotic lesions…)\n* Presence of ulcerative-necrotic gingivitis or periodontitis\n* Presence of endo-periodontal lesions\n* Chronic or systemic pathology or treatment that can influence the periodontal microbiota : immunotherapy, corticosteroid therapy, biotherapy, unbalanced diabetes, acute inflammatory rheumatism, neurological impairment…\n* Antibiotic during the 3 month preceding inclusion\n* Psychological or linguistic disability preventing good understanding of the study\n* Minors\n* Major patients under legal protection\n* Patients deprived of their liberty\n* Pregnant or lactating woman\n* Patient not affiliated to a health insurance scheme'}, 'identificationModule': {'nctId': 'NCT04251650', 'acronym': 'PAROMIP', 'briefTitle': 'PAROMIP Pilot Study PAROdontites & MIcrobiota Periodontal', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Search for a Microbiotic Signature Associated With Periodontitis According to the Chicago Classification 2018', 'orgStudyIdInfo': {'id': '30042019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'low severity', 'description': 'patient with periodontitis stage I and II', 'interventionNames': ['Other: subgingival plaque sample', 'Other: CGF sample']}, {'label': 'high severity', 'description': 'patient with periodontitis stage III and IV', 'interventionNames': ['Other: subgingival plaque sample', 'Other: CGF sample']}], 'interventions': [{'name': 'subgingival plaque sample', 'type': 'OTHER', 'description': 'for subgingival plaque sample, on three affected sites (PD\\>3mm) and three healthy sites (PD≤3mm), after supra-gingival plaque removal, sterile endodontic paper points were inserted in selects pockets for 30s to collect the subgingival plaque. The material was transferred into eppendorf tube, one for affected samples and one for healthy samples.', 'armGroupLabels': ['high severity', 'low severity']}, {'name': 'CGF sample', 'type': 'OTHER', 'description': 'each site was sampled with a PerioPaper Strip® (Oraflow), and the volumes collected were measured with a Periotron® (Oraflow). Then samples of affected sites were stowed in an eppendorf tube with 120µL of PBS Tween. The same procedure was performed for the healthy sites', 'armGroupLabels': ['high severity', 'low severity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'state': 'Loire Atlantique', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Assem Soueidan, PU-PH', 'role': 'CONTACT', 'email': 'assem.soueidan@chu-nantes.fr', 'phone': '+33 2 40 41 29 23'}, {'name': 'Assem SOUEIDAN, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nantes Universitary Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'centralContacts': [{'name': 'Assem SOUEIDAN, Pr', 'role': 'CONTACT', 'email': 'assem.soueidan@chu-nantes.fr', 'phone': '02.40.41.29.23', 'phoneExt': '+(33)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}