Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-01-18 @ 3:34 AM
Study NCT ID:
NCT06135792
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2023-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Arginine on Biofilm Composition, Architecture and Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D003773', 'term': 'Dental Plaque'}, {'id': 'D003141', 'term': 'Communicable Diseases'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001120', 'term': 'Arginine'}], 'ancestors': [{'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Split-mouth design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2023-11-13', 'studyFirstSubmitQcDate': '2023-11-13', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biofilm pH', 'timeFrame': 'Measured after in situ biofilm growth', 'description': 'Extracellular biofilm pH measured after sucrose challenge using pH ratiometry'}], 'secondaryOutcomes': [{'measure': 'Biofilm microbial composition', 'timeFrame': 'Analyzed after in situ biofilm growth', 'description': 'Microbial community of dental biofilms determined by 16S rRNA gene sequencing. Distribution of specific microbial targets in the biofilms is visualized by fluorescence in situ hybridization.'}, {'measure': 'Biofilm matrix architecture', 'timeFrame': 'Analyzed after of in situ biofilm growth', 'description': 'Matrix components are visualized in the dental biofilms by confocal microscopy.'}, {'measure': 'Biofilm thickness', 'timeFrame': 'Measured after in situ biofilm growth', 'description': 'Measured using confocal laser scanning microscopy and/or optical coherence tomography.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Caries', 'Dental Plaque', 'Microbial Colonization']}, 'descriptionModule': {'briefSummary': 'Arginine is an adjunct to oral health care that has the potential to modulate the composition and activity of the microbial community of dental biofilms towards a health-related status without harmful effects for the resident oral microbiota. The aim of the study is to investigate the effects of arginine treatment compared to placebo on the composition, metabolism, and microarchitecture of biofilms grown in situ in the oral cavity of caries-active participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females ≥ 18 years old.\n* Three or more active carious lesions.\n* Anatomically possible to manufacture an intraoral lower-jaw splint.\n* Able to understand and follow instructions, as well as to read and sign the informed consent form.\n\nExclusion Criteria:\n\n* History of allergies towards any of the ingredients in the test products\n* Self-reported pregnant or nursing\n* Antibiotic or anti-inflammatory medication within 90 days of the screening visit.\n* Orthodontic appliances, including retainers, or removable partial dentures.\n* Self-reported serious medical conditions.'}, 'identificationModule': {'nctId': 'NCT06135792', 'briefTitle': 'The Effect of Arginine on Biofilm Composition, Architecture and Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'The Effect of Arginine on Biofilm Composition, Architecture and Metabolism in Caries-active Patients: a Split-mouth in Situ Trial', 'orgStudyIdInfo': {'id': '97473'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arginine solution', 'description': 'Arginine treatment is performed outside the oral cavity (ex vivo) by immersing one side of a splint into a solution of arginine 1.5% (w/v). Treatment is performed 3 times a day for 30 min.', 'interventionNames': ['Other: Arginine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo treatment is performed outside the oral cavity (ex vivo) by immersing one side of a splint into distilled water. Treatment is performed 3 times a day for 30 min.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Arginine', 'type': 'OTHER', 'description': 'See arm description', 'armGroupLabels': ['Arginine solution']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'See arm description', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Sebastian Schlafer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aarhus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to general data protection regulations, individual participant data will not be made available publicly. Summary data will be made available upon publication of the results.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}