Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-01-02 @ 8:02 AM
Study NCT ID:
NCT01501357
Status:
COMPLETED
Last Update Posted:
2018-03-21
First Post:
2011-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Toothbrushing Techniques in Plaque Removal and Caries Lesion Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058225', 'term': 'Plaque, Amyloid'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-20', 'studyFirstSubmitDate': '2011-12-20', 'studyFirstSubmitQcDate': '2011-12-23', 'lastUpdatePostDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'dental caries', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'dental plaque', 'timeFrame': '24 months', 'description': 'Dental plaque accumulation after short and long term analysis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['caries', 'primary molars', 'plaque', 'toothbrushing'], 'conditions': ['Caries']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the effectiveness of cross-toothbrushing technique compared with anteroposterior and biofilm removal and control of caries lesions in first permanent molars.', 'detailedDescription': '220 children between 5-7 years with at least one permanent molar erupting will be selected, with a maximum score of ICDAS 3. These children will be randomly allocated into two groups according to the technique adopted. The teeth will be evaluated by ICDAS, laser fluorescence (DIAGNOdent), QLF and subtraction radiography at baseline and after 15 days, 3, 6, 9,12,18,24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* erupting primary permanent molar\n\nExclusion Criteria:\n\n* caries ( ICDAS 4,5 and 6),\n* enamel defects,\n* sealant,\n* restoration'}, 'identificationModule': {'nctId': 'NCT01501357', 'acronym': 'toothbrushing', 'briefTitle': 'Effectiveness of Toothbrushing Techniques in Plaque Removal and Caries Lesion Control', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effectiveness of Toothbrushing Techniques in Plaque Removal and Caries Lesion Control in Erupting Primary Permanent Molars - Randomized Clinical Trial Abbreviated Over 24 Months', 'orgStudyIdInfo': {'id': '001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'multilevel filaments toothbrush', 'description': 'Children will brush with anteroposterior toothbrushing and a modified toothbrush (multilevel filaments)', 'interventionNames': ['Behavioral: modified toothbrush with multilevel filaments']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'cross toothbrushing', 'description': 'Children will brush with cross toothbrushing.', 'interventionNames': ['Behavioral: cross toothbrushing']}], 'interventions': [{'name': 'modified toothbrush with multilevel filaments', 'type': 'BEHAVIORAL', 'otherNames': ['stages, oral b'], 'description': 'After the allocation of patients in this group they were instructed to brush their first molars erupt with the brushing technique anteroposterior.', 'armGroupLabels': ['multilevel filaments toothbrush']}, {'name': 'cross toothbrushing', 'type': 'BEHAVIORAL', 'otherNames': ['buccal-lingual technique'], 'description': 'Children allocated to the group multi-bristled brush will be modified compared to the results of the group cross toothbrushing technique', 'armGroupLabels': ['cross toothbrushing']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Mariana M Braga, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Mariana Minatel Braga', 'investigatorAffiliation': 'University of Sao Paulo'}}}}