Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT02490618
Status:
COMPLETED
Last Update Posted:
2019-02-12
First Post:
2015-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of a Probiotic Lozenge in the Treatment of Residual Pockets After Classical Non-surgical Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-11', 'studyFirstSubmitDate': '2015-05-06', 'studyFirstSubmitQcDate': '2015-07-01', 'lastUpdatePostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pocket Probing Depth (PPD) at teeth with residual pockets', 'timeFrame': '3-6 months'}, {'measure': 'Recessions (REC) at teeth with residual pockets', 'timeFrame': '3-6 months'}, {'measure': 'Clinical Attachment Loss (CAL) at teeth with residual pockets', 'timeFrame': '3-6 months'}], 'secondaryOutcomes': [{'measure': 'Plaque at teeth with residual pockets', 'timeFrame': '3-6 months'}, {'measure': 'Bleeding on Probing (BoP) at teeth with residual pockets', 'timeFrame': '3-6 months'}, {'measure': 'Overall PPD, REC, CAL', 'timeFrame': '3-6 months'}, {'measure': 'Microbial samples: deepest pocket, saliva, tongue', 'timeFrame': '3-6 months'}, {'measure': 'Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS)', 'timeFrame': '3-6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in patients with residual bleeding pockets of ≥ 5mm 3 months following scaling and rootplaning. Simultaneously the additional benefit of subgingival application of probiotics via oil drops will be investigated.', 'detailedDescription': 'The aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in patients with residual bleeding pockets of ≥ 5mm following scaling and rootplaning. Simultaneously the additional benefit of subgingival application of probiotics via oil drops will be investigated.\n\nRecruitment: This study will be a single centre (Department of Oral Health Sciences, University Hospitals Leuven), double blind, randomized, placebo controlled clinical trial with within each patient a split mouth design. The randomization (by means of a computer program) and double blind design are thought to minimize the bias of the investigator and patients.\n\nSelection of the study population: Adults, who consult at the department of Periodontology at the University Hospital Leuven, and who fit the inclusion criteria will be asked to participate in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 40 patients\n* ≥ 18 years of age\n* scaling and rootplaning received at least 3 months ago\n* Patients diagnosed with residual pockets (at least 2), with the definition of residual pockets:\\> 5mm or 5 and BOP+\n* Willing and able to give written informed consent\n\nExclusion Criteria:\n\n* patients with aggressive periodontitis\n* patients who smoke\n* pregnant or lactating woman\n* patients with poorly controlled diabetes\n* patients taking bisphosphonate mediation\n* patient who had taken systemic antibiotics 3 months prior to treatment'}, 'identificationModule': {'nctId': 'NCT02490618', 'briefTitle': 'The Use of a Probiotic Lozenge in the Treatment of Residual Pockets After Classical Non-surgical Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'The Use of a Probiotic Lozenge in the Treatment of Residual Pockets After Classical Non-surgical Therapy', 'orgStudyIdInfo': {'id': 's57667'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test', 'description': 'Probiotic tablet', 'interventionNames': ['Other: Probiotic tablet- Biogaia']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Control tablet', 'interventionNames': ['Other: Placebo tablet']}], 'interventions': [{'name': 'Probiotic tablet- Biogaia', 'type': 'OTHER', 'armGroupLabels': ['Test']}, {'name': 'Placebo tablet', 'type': 'OTHER', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZLeuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'BioGaia AB', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}