Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2026-01-07 @ 9:24 PM
Study NCT ID:
NCT06589193
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Clinical and Microbiological Effects of CHX and HOCl Containing Mouthwashes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003773', 'term': 'Dental Plaque'}, {'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '4-day plaque regrowth study model'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2024-08-29', 'studyFirstSubmitQcDate': '2024-09-05', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plaque index', 'timeFrame': '1 month', 'description': 'Plaque index results were evaluated regionally and full mouth for CHX and HOCl groups.'}], 'secondaryOutcomes': [{'measure': 'microbiology', 'timeFrame': '1 month', 'description': 'Microbiological data were evaluated on plaque samples taken from molar teeth for CHX and HOCl groups.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypochlorous acid', 'chlorhexidine gluconate', 'antiplaque', 'anti-inflammatory', 'gingivitis'], 'conditions': ['Dental Plaque']}, 'referencesModule': {'references': [{'pmid': '29608039', 'type': 'BACKGROUND', 'citation': 'Lafaurie GI, Zaror C, Diaz-Baez D, Castillo DM, De Avila J, Trujillo TG, Calderon-Mendoza J. Evaluation of substantivity of hypochlorous acid as an antiplaque agent: A randomized controlled trial. Int J Dent Hyg. 2018 Nov;16(4):527-534. doi: 10.1111/idh.12342. Epub 2018 Apr 2.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to compare the antiplaque and anti-inflammatory effects of HOCl mouth rinse with those of CHX mouth rinse. The secondary objective is to evaluate and compare the antimicrobial activities of HOCl mouth rinse and CHX mouth rinse on dental biofilm.', 'detailedDescription': 'The primary objective of the current clinical study is to compare the antiplaque and anti-inflammatory efficacy of HOCl mouth rinse with that of CHX mouth rinse. The secondary objective is to compare the antimicrobial activities of these two mouth rinses on dental biofilm. This single-center, triple-blind, randomized controlled crossover study was completed with 26 participants. In the study, the same participants used both HOCl (0.02%) and CHX (0.2%) mouth rinses over a 4-day re-plaque formation model. Following each mouth rinse usage, supragingival dental plaque biofilm samples were collected, and clinical parameters including the Modified Plaque Index, Bleeding on Probing Index, and Modified Stain Index were recorded. Additionally, participants were asked to evaluate the mouth rinses they used via a questionnaire. In conclusion, HOCl mouth rinse has demonstrated antiplaque efficacy comparable to that of CHX mouth rinse. When evaluating total bacterial counts, both mouth rinses exhibited similar antimicrobial effectiveness. Within the limitations of this study, HOCl may be considered a promising antimicrobial agent for dental plaque control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being systematically healthy\n* Having at least 22 natural teeth (236)\n* Not smoking\n* Participants must not drink alcohol and must work during their term\n\nExclusion Criteria:\n\n* Having periodontitis and gingivitis\n* Being breastfeeding or pregnant\n* Using medication that may affect periodontal status\n* Having used antibiotics in the last month\n* Having used any mouthwash in the last month\n* Using fixed, removable dentures or orthodontic appliances'}, 'identificationModule': {'nctId': 'NCT06589193', 'briefTitle': 'Comparison of the Clinical and Microbiological Effects of CHX and HOCl Containing Mouthwashes', 'organization': {'class': 'OTHER', 'fullName': 'Baskent University'}, 'officialTitle': 'Comparison of the Clinical and Microbiological Effects of CHX and HOCl Containing Mouthwashes', 'orgStudyIdInfo': {'id': 'MR1234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HOCl', 'interventionNames': ['Other: HOCl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CHX', 'interventionNames': ['Other: CHX']}], 'interventions': [{'name': 'HOCl', 'type': 'OTHER', 'description': '10ml,twice a day', 'armGroupLabels': ['HOCl']}, {'name': 'CHX', 'type': 'OTHER', 'description': '10ml,twice a day', 'armGroupLabels': ['CHX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Baskent University Faculty of Dentistry', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Mehtap Bilgin Cetin, Assoc. prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Başkent Üniversitesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baskent University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Mehtap Bilgin Çetin', 'investigatorAffiliation': 'Baskent University'}}}}