Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2025-12-26 @ 6:56 PM
Study NCT ID:
NCT05268757
Status:
COMPLETED
Last Update Posted:
2022-08-23
First Post:
2022-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Probiotics on Oral Homeostasis During Oral Hygiene Discontinuation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'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'], 'maskingDescription': 'Computerized randomization only known to the principal investigator, who are not directly involved in data collection or data analysis'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blinded randomized clinical trial with a test and placebo group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-22', 'studyFirstSubmitDate': '2022-02-24', 'studyFirstSubmitQcDate': '2022-02-24', 'lastUpdatePostDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in salivary levels of inflammatory cytokines', 'timeFrame': 'Baseline vs. Day 14 and Day 28', 'description': 'Changes in mean salivary levels of selected inflammatory cytokines'}], 'primaryOutcomes': [{'measure': 'Changes in microbial composition in dental', 'timeFrame': 'Baseline vs. Day 14 and Day 28', 'description': 'Changes in alpha and beta diversity of microbial composition'}], 'secondaryOutcomes': [{'measure': 'Changes in clinical parameters', 'timeFrame': 'Baseline vs. Day 14 and Day 28', 'description': 'Changes in levels of dental plaque and gingival inflammation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingivitis']}, 'descriptionModule': {'briefSummary': 'The present study is a double-blinded randomized clinical trial with a duration of 28 days.', 'detailedDescription': 'The present study is a double-blinded randomized clinical trial with a duration of 28 days.\n\n80 orally and systemically healthy participant will be allocated in the test (probiotic) and the control (placebo) group at baseline.\n\nThe intervention is oral hygiene discontinuation, which will be applied at baseline and continue through day 14, followed by 14 days with regular oral care.\n\nClinical measurements and sampling will be performed at baseline, day 14 and day 28\n\nPrimary endpoint: Changes in microbial composition.\n\nSecondary endpoints: Changes in clinical and immunological parameters'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- age \\> 18 yrs.\n\nExclusion Criteria:\n\n* Presence of oral diseases i.e. gingivitis, periodontitis and dental caries\n* Current smokers\n* Any systemic diseases and current use of any medication with known effect on oral health\n* Use of systemic antibiotics within the latest three months\n* Age \\< 18 yrs., and age \\> 30 yrs.'}, 'identificationModule': {'nctId': 'NCT05268757', 'briefTitle': 'Effect of Probiotics on Oral Homeostasis During Oral Hygiene Discontinuation', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Effect of Probiotics on Oral Homeostasis During Oral Hygiene Discontinuation', 'orgStudyIdInfo': {'id': 'UCPH_01_006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic', 'description': 'In this group participants will receive probiotic supplements twice a day (morning and evening) for at period of 28 days (14 days with oral hygiene discontinuation followed by 14 days with regular oral care).', 'interventionNames': ['Behavioral: Oral hygiene discontinuation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'In this group participants will receiveplacebo twice a day (morning and evening) for at period of 28 days (14 days with oral hygiene discontinuation followed by 14 days with regular oral care).', 'interventionNames': ['Behavioral: Oral hygiene discontinuation']}], 'interventions': [{'name': 'Oral hygiene discontinuation', 'type': 'BEHAVIORAL', 'description': 'Oral hygiene discontinuation for 14 days followed by 14 days of regular oral care', 'armGroupLabels': ['Placebo', 'Probiotic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2200', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'University of Copenhagen, Department of Odontology', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Deerland Probiotics and Enzymes', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS, PhD, Dr. odont', 'investigatorFullName': 'Daniel Belstrøm, DDS, PhD', 'investigatorAffiliation': 'University of Copenhagen'}}}}