Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-03-03 @ 3:53 PM
Study NCT ID:
NCT02830802
Status:
COMPLETED
Last Update Posted:
2018-05-02
First Post:
2016-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial for Evaluating Sage-Based Mouthrinse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013282', 'term': 'Stomatitis, Denture'}, {'id': 'D014075', 'term': 'Tooth Discoloration'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D013280', 'term': 'Stomatitis'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003358', 'term': 'Cosmetics'}], 'ancestors': [{'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D006795', 'term': 'Household Products'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-01', 'studyFirstSubmitDate': '2016-07-01', 'studyFirstSubmitQcDate': '2016-07-08', 'lastUpdatePostDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sulcus Bleeding Index', 'timeFrame': 'six weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stomal Bleeding', 'Stomatitis, Denture', 'Tooth Staining', 'Satisfaction']}, 'descriptionModule': {'briefSummary': 'The investigators aim to evaluate a sage-based mouthrinse (Dr. Hauschka Med, Mundspülung Salbei) whether it is less or equal effective in alleviating inflammatory signs of intra-oral mucosa and gingiva than an water/alcohol-based taste adjusted placebo in patients dependent on ADL.\n\nRandomization in treatment A (mouthwash with active agent, n=24) or treatment B (placebo mouthwash, n=24) Supervised use of mouthwash A or mouthwash B over 6 weeks 1x/day additional to habitual oral hygiene protocol.\n\nThe main outcome parameter will be Sulcus Bleeding Index SBI.', 'detailedDescription': 'A sage-based mouthrinse based on an extract from Salvia officinalis in a composition with extracts from Althaea Officinalis, Aesculus Hippocatanum Bark and essential oils might comprise an alternative to conventional antimicrobial mouthrinses, which might exhibit important side effects. Thus the aim of the current study is to test the null-hypothesis H0:\n\nA sage-based mouthrinse (Dr. Hauschka Med, Mundspülung Salbei, WALA Heilmittel GmbH, Dorfstraße 1, 73087 Bad Boll/Eckwälden, Germany) is less or equal effective in alleviating inflammatory signs of intra-oral mucosa and gingiva than an water/alcohol-based taste adjusted placebo.\n\nThe placebo and the sage-based mouthrinse will be manufactured according to EU-Kosmetik-Verordnung 1223/2009 and provided by WALA Heilmittel GmbH, Dorfstraße 1, 73087 Bad Boll/Eckwälden, Germany together with the necessary safety documentation. The placebo will be an alcohol/ water based solution with a similar taste to the tested mouthrinse.\n\nThe main outcome parameter will be Sulcus Bleeding Index SBI. Among others, the main secondary outcome parameters will be Oral Health Related Quality of Life as assessed with the OHIP-14 G questionnaire, the Xerostomia inventory and a Tooth staining index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to give informed consent, i.e. no legal guardian appointed\n* Willing to participate\n* Depended on their ADLs (IADL)(24)\n* Sulcus Bleeding Index (SBI) \\> 50%\n\nExclusion Criteria:\n\n* Allergy to one of the components\n* Edentulous\n* Alcohol dependency\n* Prescription of antibiotics and/ or immunosuppressives (e.g. glucocorticoids) Anti-inflammatory mouthrinse -'}, 'identificationModule': {'nctId': 'NCT02830802', 'briefTitle': 'Clinical Trial for Evaluating Sage-Based Mouthrinse', 'organization': {'class': 'OTHER', 'fullName': 'University of Bern'}, 'officialTitle': 'Randomized Controlled Clinical Trial for Evaluating a Sage-based Mouthrinse in Regard to Its Anti-inflammatory Potential in Elderly Patients Which Are Dependent in Their ADLs', 'orgStudyIdInfo': {'id': 'gerodont_3: Sage Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Active Agent', 'interventionNames': ['Other: Dr. Hauschka Med Mundspüllösung Salbei / cosmetics']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B', 'description': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Dr. Hauschka Med Mundspüllösung Salbei / cosmetics', 'type': 'OTHER', 'description': 'Supervised use over 6 weeks 1x/day additional to habitual oral hygiene protocol.\n\nFor an application fill the closure cap with the mouthwash. Rinse the mouth vigorously for 30 seconds, for easier timekeeping use the hourglass. Then spit out the mouthwash, do not rinse.', 'armGroupLabels': ['Group A']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Supervised use over 6 weeks 1x/day additional to habitual oral hygiene protocol.\n\nFor an application fill the closure cap with the mouthwash.', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'University of Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Martin Schimmel, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Bern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'WALA Heilmittel GmbH', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}