Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-14 @ 3:48 AM
Study NCT ID:
NCT06692595
Status:
COMPLETED
Last Update Posted:
2024-11-18
First Post:
2024-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital PCR for Quantifying Periodontal Pathobionts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Subgingival plaque sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2024-11-14', 'studyFirstSubmitQcDate': '2024-11-14', 'lastUpdatePostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'concentration of targeted bacterial species, expressed as genome equivalents per mL (Geq/mL), normalized for ribosomal gene copy number per cell', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontal Diseases']}, 'descriptionModule': {'briefSummary': 'Comparison of quantitative polymerase chain reaction (qPCR) and digital polimerase chain reaction (dPCR) quantification of subgingival plaque samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study comprised of two subject groups. The first group consisted of 20 subjects with periodontitis, who had at least one probing site in each jaw quadrant with pocket depth (PPD) measuring \\> 4 mm and positive bleeding on probing (BOP). Periodontitis stage and grade were determined following the 2018 classification system.\n\nThe second group consisted of 20 volunteers without periodontal pathologies (healthy group), i.e. plaque index \\< 10% at baseline visit, absence of periodontal pockets measuring \\> 4 mm and no prior periodontal treatment.', 'healthyVolunteers': True, 'eligibilityCriteria': 'For inclusion, each subject had to be systemically healthy and aged 20 to 80 years. Subjects were excluded if they: had less than 5 teeth in each jaw quadrant, regularly used a mouthwash as part of their oral hygiene routine, had received antibiotics during the last 6 months or during the study period, were pregnant or lactating, had a known systemic illness (i.e. HIV/AIDS, diabetes mellitus, cancer, diseases of bone metabolism, diseases affecting wound healing) or were treated with immunosuppressants, chemotherapy, radiation, calcium antagonists, antiepileptics and non-steroidal anti-inflammatory drugs.'}, 'identificationModule': {'nctId': 'NCT06692595', 'acronym': 'dPCR', 'briefTitle': 'Digital PCR for Quantifying Periodontal Pathobionts', 'organization': {'class': 'OTHER', 'fullName': 'University of Ljubljana'}, 'officialTitle': 'Digital PCR for Quantifying Periodontal Pathobionts: A Comparative Study With qPCR', 'orgStudyIdInfo': {'id': 'UKCdPCR1'}, 'secondaryIdInfos': [{'id': 'J7-4639', 'type': 'OTHER_GRANT', 'domain': 'ARIS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Periodontitis patients', 'interventionNames': ['Diagnostic Test: digital PCR']}, {'label': 'Individuals with healthy periodontium', 'interventionNames': ['Diagnostic Test: digital PCR']}], 'interventions': [{'name': 'digital PCR', 'type': 'DIAGNOSTIC_TEST', 'description': 'digital PCR quantification of subgingival plaque samples', 'armGroupLabels': ['Individuals with healthy periodontium', 'Periodontitis patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'University Medical Centre Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof., PhD', 'investigatorFullName': 'Rok Gašperšič', 'investigatorAffiliation': 'University of Ljubljana'}}}}