Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2025-12-24 @ 3:48 PM
Study NCT ID:
NCT03956992
Status:
COMPLETED
Last Update Posted:
2020-01-30
First Post:
2019-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of a Hydroxyapatite-based Mouth Gel on Calcium Content of Plaque
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-29', 'studyFirstSubmitDate': '2019-05-17', 'studyFirstSubmitQcDate': '2019-05-17', 'lastUpdatePostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Calcium content of plaque', 'timeFrame': '3 days', 'description': 'Analysis by atomic absorption spectroscopy (AAS)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Caries']}, 'referencesModule': {'references': [{'pmid': '6580080', 'type': 'BACKGROUND', 'citation': 'Shaw L, Murray JJ, Burchell CK, Best JS. Calcium and phosphorus content of plaque and saliva in relation to dental caries. Caries Res. 1983;17(6):543-8. doi: 10.1159/000260715. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this pilot study is to analyze if a hydroxyapatite-containing mouth gel has an influence on the calcium content of plaque.', 'detailedDescription': '\\>= 20 subjects (7-11 years) use the hydroxyapatite-containing mouth gel for 3 days (3x per day); without using any other oral care product at this time. A dentist applies the gel on all teeth. At baseline and after 3 days plaque will be collected from buccal and labial surfaces (except surfaces with tartar). A "split-mouth" concept will be used:\n\nSubjects in group A:\n\nBaseline plaque collection: quadrant 1 and 4 Plaque collection after 3 days: quadrant 2 and 3\n\nSubjects in group B:\n\nBaseline plaque collection: quadrant 2 and 3 Plaque collection after 3 days: quadrant 1 and 4 (The time between last application of the gel and plaque collection will be 1 h) The plaque will be dried and afterwards the calcium content of the plaque will be quantitively analyzed by atomic absorption spectroscopy (AAS).\n\nFor all subjects: Calcium contents of plaque at baseline and after 3 days application will be compared by statistical methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Girls and boys (7-11 years)\n* Visible plaque\n* \\>= 4 teeth\n* Good overall health\n\nExclusion Criteria:\n\n* Allergic to one or more ingredients of the mouth gel\n* Medication intake (e.g. antibiotics)\n* Any other reason that, in the opinion of the investigator, disqualifies the subject from participating in the study'}, 'identificationModule': {'nctId': 'NCT03956992', 'briefTitle': 'Effects of a Hydroxyapatite-based Mouth Gel on Calcium Content of Plaque', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dr. Kurt Wolff GmbH & Co. KG'}, 'officialTitle': 'Effects of a Hydroxyapatite-based Mouth Gel on Calcium Content of Plaque', 'orgStudyIdInfo': {'id': 'Dr. Kurt Wolff'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mouth gel', 'description': 'A mouth gel with hydroxyapatite', 'interventionNames': ['Other: Mouth gel']}], 'interventions': [{'name': 'Mouth gel', 'type': 'OTHER', 'description': 'Stop using the mouth gel', 'armGroupLabels': ['Mouth gel']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bali', 'state': 'Kebon Padangan', 'country': 'Indonesia', 'facility': 'Health department', 'geoPoint': {'lat': -7.65361, 'lon': 111.08444}}], 'overallOfficials': [{'name': 'Henny Sudradjat', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department for Dentistry, Health Care Center, Braunschweig, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Joachim Enax', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Scientist Oral Care', 'investigatorFullName': 'Dr. Joachim Enax', 'investigatorAffiliation': 'Dr. Kurt Wolff GmbH & Co. KG'}}}}