Ignite Creation Date:
2025-12-24 @ 5:13 PM
Ignite Modification Date:
2025-12-28 @ 9:39 PM
Study NCT ID:
NCT01819350
Status:
COMPLETED
Last Update Posted:
2013-03-27
First Post:
2013-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
In Vivo Study of Sucrose and Liquid Oral Pediatric Medicines of Long-term Effect on Dental Biofilm pH
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': 'D059951', 'term': 'HLA-G Antigens'}], 'ancestors': [{'id': 'D015395', 'term': 'Histocompatibility Antigens Class I'}, {'id': 'D008562', 'term': 'Membrane Glycoproteins'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D006649', 'term': 'Histocompatibility Antigens'}, {'id': 'D000954', 'term': 'Antigens, Surface'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D006680', 'term': 'HLA Antigens'}, {'id': 'D007519', 'term': 'Isoantigens'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-24', 'studyFirstSubmitDate': '2013-03-24', 'studyFirstSubmitQcDate': '2013-03-24', 'lastUpdatePostDateStruct': {'date': '2013-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of group respiratory, nutritional and endocrine pediatric medicines effect on dental biofilm pH', 'timeFrame': '6 months', 'description': 'pH was measured in the cervical and proximal regions of anterior teeth dental biofilm with beetrode-type microelectrode coupled to a potentiometer'}], 'secondaryOutcomes': [{'measure': 'Evaluation of sucrose antibiotic group and control negative group effect on dental biofilm', 'timeFrame': '12 months', 'description': 'The biofilm was submitted antibiotic group and negative control group. pH measurements were taken at baseline to determine resting plaque pH and at time interval 5, 10, 15, 20, 25 and 30 minutes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dental caries', 'Sucrose', 'Oral administration', 'Ion Concentration of Hydrogen', 'Pediatric medicines'], 'conditions': ['Dental Biofilm pH']}, 'descriptionModule': {'briefSummary': 'The aims of this study were to determine the sucrose and liquid oral pediatric medicines of long-term effect on dental biofilm pH to evaluate the cariogenic potential in vivo.', 'detailedDescription': 'Te study was carried out with 12 subjects that were refrained from brushing their teeth for 28 h and did not eat or drink for at least 3 h prior to each appointment. Dental biofilm pH was measured in the cervical and proximal regions of anterior teeth with beetrode-type microelectrode coupled to a potentiometer. The biofilm was submitted nine paediatric medicines a long term and sucrose (negative control). pH measurements were taken at baseline to determine resting plaque pH and at time interval 5, 10, 15, 20, 25 and 30 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '22 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 22 years;\n* Having Oral hygiene adequate (OHI\\<1.1);\n* Having 20 natural teeth incluing molar;\n* Not havind oral disease.\n\nExclusion Criteria:\n\n* Biofilm baseline pH \\> 5,5;\n* Not signature consent term;\n* Using orthodontic appliance;\n* Having used medicines last 3 months;\n* Pregant woman.'}, 'identificationModule': {'nctId': 'NCT01819350', 'acronym': 'SPMedicines', 'briefTitle': 'In Vivo Study of Sucrose and Liquid Oral Pediatric Medicines of Long-term Effect on Dental Biofilm pH', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Paraíba'}, 'officialTitle': 'Avaliação in Vivo do Potencial cariogênico e Erosivo de Bebidas e Medicamentos pediátricos líquidos Intra-orais', 'orgStudyIdInfo': {'id': 'SOPM-UFPB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'G4 and G5', 'description': 'Application of antibiotic group of pediatric medicines and control group (sucrose 10 %)on dental biofilm.', 'interventionNames': ['Other: G4 and G5']}, {'type': 'EXPERIMENTAL', 'label': 'G1, G2 and G3', 'description': 'Application of Nutritional, Respiratory and Endocrine groups medicines pediatric on dental biofilm', 'interventionNames': ['Other: G1, G2 and G3']}], 'interventions': [{'name': 'G1, G2 and G3', 'type': 'OTHER', 'description': 'Nutritional, respiratory and endocrine group applicated 12 subjects', 'armGroupLabels': ['G1, G2 and G3']}, {'name': 'G4 and G5', 'type': 'OTHER', 'description': 'Application of trhree pediadic medidines of antibiotic group on dental biofilm 12 subjects', 'armGroupLabels': ['G4 and G5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58051900', 'city': 'João Pessoa', 'state': 'Paraíba', 'country': 'Brazil', 'facility': 'Federal University of Paraíba', 'geoPoint': {'lat': -7.115, 'lon': -34.86306}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Paraíba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Fabio Correia Sampaio', 'investigatorAffiliation': 'Federal University of Paraíba'}}}}