Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT01589458
Status:
COMPLETED
Last Update Posted:
2012-05-02
First Post:
2012-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fluoride Availability in Saliva After Use of Sodium Fluoride or Monofluorophosphate Toothpastes
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014100', 'term': 'Toothpastes'}], 'ancestors': [{'id': 'D003802', 'term': 'Dentifrices'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-01', 'studyFirstSubmitDate': '2012-04-29', 'studyFirstSubmitQcDate': '2012-05-01', 'lastUpdatePostDateStruct': {'date': '2012-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the curve of salivary fluoride concentration versus time after brushing with fluoride toothpastes', 'timeFrame': '60 minutes'}], 'secondaryOutcomes': [{'measure': 'Percentage of MFP hydrolyzed in saliva as a function of time', 'timeFrame': '60 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['toothpastes', 'saliva', 'dental caries', 'fluoride'], 'conditions': ['Dental Caries']}, 'referencesModule': {'references': [{'pmid': '15798817', 'type': 'BACKGROUND', 'citation': 'Cury JA, Tenuta LM, Ribeiro CC, Paes Leme AF. The importance of fluoride dentifrices to the current dental caries prevalence in Brazil. Braz Dent J. 2004;15(3):167-74. doi: 10.1590/s0103-64402004000300001. Epub 2005 Mar 18.'}, {'pmid': '22460314', 'type': 'BACKGROUND', 'citation': 'Ricomini Filho AP, Tenuta LM, Fernandes FS, Calvo AF, Kusano SC, Cury JA. Fluoride concentration in the top-selling Brazilian toothpastes purchased at different regions. Braz Dent J. 2012;23(1):45-8. doi: 10.1590/s0103-64402012000100008.'}, {'pmid': '21180793', 'type': 'BACKGROUND', 'citation': 'Cury JA, Oliveira MJ, Martins CC, Tenuta LM, Paiva SM. Available fluoride in toothpastes used by Brazilian children. Braz Dent J. 2010;21(5):396-400. doi: 10.1590/s0103-64402010000500003.'}, {'pmid': '20857070', 'type': 'BACKGROUND', 'citation': 'Tenuta LM, Cury JA. Fluoride: its role in dentistry. Braz Oral Res. 2010;24 Suppl 1:9-17. doi: 10.1590/s1806-83242010000500003.'}, {'pmid': '22182293', 'type': 'BACKGROUND', 'citation': 'Carrera CA, Giacaman RA, Munoz-Sandoval C, Cury JA. Total and soluble fluoride content in commercial dentifrices in Chile. Acta Odontol Scand. 2012 Dec;70(6):583-8. doi: 10.3109/00016357.2011.640287. Epub 2011 Dec 20.'}]}, 'descriptionModule': {'briefSummary': 'Considering the widespread use of sodium fluoride (NaF) and monofluorophosphate (MFP) based toothpastes, the present study aim to evaluate F availability in saliva after use of the top-selling Brazilian toothpastes. In a blind, crossover clinical trial study, volunteers will brush their teeth with one of the following toothpastes: 1) non-fluoride toothpaste (negative control group); 2) NaF/silica based toothpaste 3)MFP/calcium carbonate based toothpaste. After brushing, a rinse with purified water will be performed. Unstimulated saliva will be collected before and up to 60 min after brushing. Ionic fluoride and total soluble fluoride (corresponding to the sum of fluoride as ion and as MFP) will be determined after acid treatment of salivary samples to hydrolyze MFP. Fluoride will be determined using an ion selective electrode.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Good general health\n* Good oral health\n* Normal salivary flow rate\n\nExclusion Criteria:\n\n* Use of systemic drugs that reduce salivary flow rate'}, 'identificationModule': {'nctId': 'NCT01589458', 'briefTitle': 'Fluoride Availability in Saliva After Use of Sodium Fluoride or Monofluorophosphate Toothpastes', 'organization': {'class': 'OTHER', 'fullName': 'University of Campinas, Brazil'}, 'officialTitle': 'Fluoride Availability in Saliva After Use of NaF or MFP Toothpastes', 'orgStudyIdInfo': {'id': 'FOPBioq003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Non-fluoride toothpaste', 'interventionNames': ['Drug: Toothpaste']}, {'type': 'EXPERIMENTAL', 'label': 'NaF/SiO2 toothpaste', 'interventionNames': ['Drug: Toothpaste']}, {'type': 'EXPERIMENTAL', 'label': 'MFP/CaCO3 toothpaste', 'interventionNames': ['Drug: Toothpaste']}], 'interventions': [{'name': 'Toothpaste', 'type': 'DRUG', 'description': '1-min brushing with 1 g of the assigned toothpaste followed by a 10 mL purified water rinse', 'armGroupLabels': ['MFP/CaCO3 toothpaste', 'NaF/SiO2 toothpaste', 'Non-fluoride toothpaste']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13414903', 'city': 'Piracicaba', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Piracicaba Dental School, University of Campinas', 'geoPoint': {'lat': -22.72528, 'lon': -47.64917}}], 'overallOfficials': [{'name': 'Livia MA Tenuta, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Piracicaba Dental School, University of Campinas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campinas, Brazil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Biochemistry and Cariology', 'investigatorFullName': 'Livia Maria Andaló Tenuta', 'investigatorAffiliation': 'University of Campinas, Brazil'}}}}