Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-02-25 @ 5:48 PM
Study NCT ID:
NCT05548361
Status:
COMPLETED
Last Update Posted:
2025-06-15
First Post:
2022-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Chlorhexidine and a Probiotic Lozenge in the Nonsurgical Therapy of Periodontitis
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': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2022-09-12', 'studyFirstSubmitQcDate': '2022-09-16', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'probing pocket depth', 'timeFrame': '6 months', 'description': 'the distance between gingival margin and pocket base in millimeters'}], 'secondaryOutcomes': [{'measure': 'percentage of patients in low risk for disease progression', 'timeFrame': '6 months', 'description': 'having less than 5 sites with probing pocket depth of 5 mm or more at the end of the trial.'}, {'measure': 'gingival recession', 'timeFrame': '6 months', 'description': 'the distance between cementoenamel junction and gingival margin in millimeters'}, {'measure': 'clinical attachment level', 'timeFrame': '6 months', 'description': 'the distance between cementoenamel junction and pocket base in millimeters'}, {'measure': 'full mouth bleeding and plaque score', 'timeFrame': '6 months', 'description': 'the scores of bleeding on probing (positive or negative)'}, {'measure': 'microbial outcomes', 'timeFrame': '6 months', 'description': 'pcr analysis of plaque samples (mean log10 cfg/ml)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontitis', 'Chlorhexidine', 'Probiotic']}, 'descriptionModule': {'briefSummary': 'The aim of this study is determining the additional effect of a 2-week home usage of chlorhexidine in periodontitis patients undergoing scaling and root planing supplemented with a dual-strain probiotic lozenge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with generalized (\\>30% of teeth affected) periodontitisstage III and IV periodontitis, grade B or C (C only with smoker modifier) = generalized chronic periodontitis including smokers\n* A minimum of three natural teeth in each quadrant, excluding third molars\n* Willing and able to give informed consent\n* Not more than 50% of the patients in each group will be smokers.\n* Smokers should smoke between 10 to 40 cigarettes a day\n\nExclusion Criteria:\n\n* Patients with localized periodontitis or periodontitis stage I or II or grade A or grade C or grade C with diabetes modifier\n* Patients with orthodontic appliances (removable or fixed)\n* Pregnant or lactating woman\n* Patients with a history of systemic diseases that may correlate with periodontal health, such as diabetesrheumatic fever, liver or kidney disease, and neurological deficiencies\n* Patients taking medication which may affect the periodontium (bisphosphonates, phenytoin, cyclosporin, nifidepine, chronic use of non-steroidal anti-inflammatory drugs)\n* Patient who had taken systemic antibiotics up to 3 months prior to treatment or medical conditions requiring prophylactic antibiotic coverage\n* Participation in any other clinical study\n* Tobacco chewing or sniffing'}, 'identificationModule': {'nctId': 'NCT05548361', 'briefTitle': 'The Use of Chlorhexidine and a Probiotic Lozenge in the Nonsurgical Therapy of Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'officialTitle': 'The Use of Chlorhexidine and a Probiotic Lozenge in the Nonsurgical Therapy of Periodontitis', 'orgStudyIdInfo': {'id': 'CukurovaU-PerII'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Chx', 'description': 'This group will receive active chlorhexidine and placebo probiotics', 'interventionNames': ['Combination Product: active chlorhexidine and placebo probiotic']}, {'type': 'EXPERIMENTAL', 'label': 'Active probiotics', 'description': 'This group will receive placeo chlorhexidine and active probiotics', 'interventionNames': ['Combination Product: placebo chlorhexidine and active probiotic']}, {'type': 'EXPERIMENTAL', 'label': 'Active Chx & probiotics', 'description': 'This group will receive active chlorhexidine and active probiotics', 'interventionNames': ['Combination Product: active chlorhexidine and active probiotic']}], 'interventions': [{'name': 'active chlorhexidine and placebo probiotic', 'type': 'COMBINATION_PRODUCT', 'description': 'the randomized patients will be receive active chlorhexidine rinse and placebo probiotic', 'armGroupLabels': ['Active Chx']}, {'name': 'placebo chlorhexidine and active probiotic', 'type': 'COMBINATION_PRODUCT', 'description': 'the randomized patients will receive placebo chlorhexidine rinse and active probiotic', 'armGroupLabels': ['Active probiotics']}, {'name': 'active chlorhexidine and active probiotic', 'type': 'COMBINATION_PRODUCT', 'description': 'the randomized patients will receive active chlorhexidine rinse and active probiotic', 'armGroupLabels': ['Active Chx & probiotics']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Cukurova university Faculty of Dentistry', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'collaborators': [{'name': 'BioGaia AB', 'class': 'INDUSTRY'}, {'name': 'Sunstar', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Mustafa Ozcan', 'investigatorAffiliation': 'Cukurova University'}}}}