Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-02-03 @ 9:14 PM
Study NCT ID:
NCT03240666
Status:
UNKNOWN
Last Update Posted:
2021-04-21
First Post:
2017-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protozoans in Biofilm From Patients With Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'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': 'Bacterial DNA, protozoan DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 231}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-20', 'studyFirstSubmitDate': '2017-07-26', 'studyFirstSubmitQcDate': '2017-08-02', 'lastUpdatePostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'presence of protozoans', 'timeFrame': '6 months after the last inclusion: DNA samples were frozen and identified later.', 'description': 'identification of protozoans by molecular technique (PCR) -'}], 'secondaryOutcomes': [{'measure': 'Periodontal pocket depth (PPD in mm)', 'timeFrame': 'One day: measure realised during examination of the patient for periodontal treatment.', 'description': 'Measure of PPD thanks to periodontal probe'}, {'measure': 'Clinical attachment Loss (CAL in mm)', 'timeFrame': 'One day: measure realied during clincal examination of patient.', 'description': 'Measure of CAL with periodontal probe'}, {'measure': 'Plaque and gingival index', 'timeFrame': 'One day: measure of index during the clinical examination of patient.', 'description': 'Measure of plaque and gingival index (Loe and Silness, Silness and Loe)'}, {'measure': 'Mobility of tooth', 'timeFrame': 'One day: measure of tooth mobility during the clinical examination of patient.', 'description': 'Measure of tooth mobility: Yes or not'}, {'measure': 'Bleeding On Probing (BOP)', 'timeFrame': 'One day: measure of BOP during the clinical examination of patient.', 'description': 'Measure of BOP : Yes or not'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontitis, Adult']}, 'descriptionModule': {'briefSummary': 'The buccal cavity is colonized by numerous microorganisms whose the number and composition could be modified with medical background (diseases and drugs) and the level of oral hygiene of the patients. Among all microorganisms identified in the periodontium, few of them are implicated in the etiopathogenesis of periodontal pathologies. To date, four major bacteria are identified for their ability to degrade periodontal tissues.\n\nAlthough the periodontitis is established to be the consequence of bacterial virulence and immune dysfunction, these factors fail to explain the refractory periodontitis of some patients to etiologic treatment .\n\nOthers microorganisms such as protozoans could have an impact on this disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients consulting to periodontal department of CHRU (Nancy-Nice- Toulouse) presenting at least two PPD of 5mm and more, without any medecines which could modify microbiota were included in this study', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults \\> 18 years-old\n* consulting in periodontal department of CHRU\n* Patients with moderate to severe periodontitis\n* At least 2 periodontal sites with PPD ≥ 5mm and one healthy site\n* No scaling root planing in the last 6 months\n* Patients insured under the Franch social security system\n\nExclusion Criteria:\n\n* Pregnants patients\n* Patients with antibiotic therapy and/ or all medecines which could modify the buccal microbiota in the last 6 months\n* Tooth with endodontics periapical lesion\n* Patients having a scaling root planing in the last 6 months\n* Patients with guardianship'}, 'identificationModule': {'nctId': 'NCT03240666', 'acronym': 'Paro-Proto', 'briefTitle': 'Protozoans in Biofilm From Patients With Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Multicentric Clinical Trials on the Prevalence of Entamoeba Gingivalis and Its Associated Bacterial Flora in Patients With Periodontitis', 'orgStudyIdInfo': {'id': 'PSS2016/PARO-PROTO-BISSON/ER'}}, 'armsInterventionsModule': {'interventions': [{'name': 'non applicable', 'type': 'OTHER', 'description': 'non applicable'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine BISSON, DDS', 'role': 'CONTACT', 'email': 'catherine.bisson@univ-lorraine.fr', 'phone': '+33 383852952'}, {'name': 'Severine VINCENT-BUGNAS, DDS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sara LAURENCINS, DDS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Catherine BISSON', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'centralContacts': [{'name': 'El Mehdi SIAGHY', 'role': 'CONTACT', 'email': 'm.siaghy@chru-nancy.fr', 'phone': '+33 383 15 52 85'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'non applicable'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}