Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-02-21 @ 1:36 AM
Study NCT ID:
NCT01901250
Status:
COMPLETED
Last Update Posted:
2014-08-12
First Post:
2013-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Xylitol for Caries Prevention in Inner-City Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D006267', 'term': 'Health Education, Dental'}], 'ancestors': [{'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011636', 'term': 'Public Health Dentistry'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sxn15@case.edu', 'phone': '216-368-3469', 'title': 'Dr. Suchitra Nelson', 'organization': 'Case Western Reserve University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Nearly half the children moved out of the school district by the time of the exit examination, which made the power of the analysis insufficient to detect the difference between two groups.'}}, 'adverseEventsModule': {'timeFrame': '9 months', 'eventGroups': [{'id': 'EG000', 'title': 'Xylitol GB', 'description': 'Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant\n\nXylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.\n\nOral health education: Oral health education, toothbrush, and fluoride toothpaste\n\nFluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.\n\nDental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted.', 'otherNumAtRisk': 260, 'otherNumAffected': 0, 'seriousNumAtRisk': 260, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fiber GB', 'description': 'Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant\n\nSugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.\n\nOral health education: Oral health education, toothbrush, and fluoride toothpaste\n\nFluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.\n\nDental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted.', 'otherNumAtRisk': 265, 'otherNumAffected': 0, 'seriousNumAtRisk': 265, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in the Number of Decayed or Filled Permanent Teeth (DFT) From Baseline (Beginning of Kindergarten) to the Middle of 2nd Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xylitol GB', 'description': 'Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant\n\nXylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.\n\nOral health education: Oral health education, toothbrush, and fluoride toothpaste\n\nFluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.\n\nDental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted.'}, {'id': 'OG001', 'title': 'Fiber GB', 'description': 'Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant\n\nSugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.\n\nOral health education: Oral health education, toothbrush, and fluoride toothpaste\n\nFluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.\n\nDental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.38', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '1.39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Permutation test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "Adjusted for child's gender, caries burden at study entry, surface-years at risk, and study cohort.", 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and middle of 2nd grade', 'description': 'The primary outcome measure was change in the number of decayed or filled permanent teeth (DFT). Caries was assessed in accordance to the International Caries Detection and Assessment System (ICDAS). The ICDAS criteria record both the severity and activity of the lesion on occlusal surfaces, in pit and fissure sites on the buccal and lingual surfaces, and on other smooth surfaces.\n\nFor the purposes of this study, an ICDAS severity score of 3 to 6 and the presence of fillings constituted the "D" and "F" portions of DFT, respectively.', 'unitOfMeasure': 'Number of surfaces', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Xylitol GB', 'description': 'Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant\n\nXylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.\n\nOral health education: Oral health education, toothbrush, and fluoride toothpaste\n\nFluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.\n\nDental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted.'}, {'id': 'FG001', 'title': 'Fiber GB', 'description': 'Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant\n\nSugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.\n\nOral health education: Oral health education, toothbrush, and fluoride toothpaste\n\nFluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.\n\nDental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '260'}, {'groupId': 'FG001', 'numSubjects': '265'}]}, {'type': 'End of Kidergarten', 'achievements': [{'groupId': 'FG000', 'numSubjects': '215'}, {'groupId': 'FG001', 'numSubjects': '212'}]}, {'type': 'Start of 1st Grade', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '176'}]}, {'type': 'End of 1st Grade', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '151'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '139'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '126'}]}]}], 'recruitmentDetails': 'Three cohorts of kindergarten children were recruited from 5 elementary schools between 2007 and 2009. A total of 32 classrooms were randomized to xylitol (16 classrooms) and placebo (16 classrooms).', 'preAssignmentDetails': 'Out of 562 children recruited, a total of 37 children did not have the baseline dental examination (13 children were transferred out of school district and 24 children were absent from the baseline dental examination).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '525', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Xylitol GB', 'description': 'Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant\n\nXylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.\n\nOral health education: Oral health education, toothbrush, and fluoride toothpaste\n\nFluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.\n\nDental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted.'}, {'id': 'BG001', 'title': 'Fiber GB', 'description': 'Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant\n\nSugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.\n\nOral health education: Oral health education, toothbrush, and fluoride toothpaste\n\nFluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.\n\nDental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '260', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '525', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black Non-Hispanic', 'categories': [{'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '461', 'groupId': 'BG002'}]}]}, {'title': 'White Non-Hispanic', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Unknown or Not reported', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Overall Caries Burden at Baseline', 'classes': [{'title': 'None (0 dmfs/DMFS)', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}]}, {'title': 'Moderate (1-5 dmfs/DMFS)', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}]}, {'title': 'Severe (6 or more dmfs/DMFS)', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 562}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-22', 'studyFirstSubmitDate': '2013-07-12', 'resultsFirstSubmitDate': '2014-07-22', 'studyFirstSubmitQcDate': '2013-07-15', 'lastUpdatePostDateStruct': {'date': '2014-08-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-22', 'studyFirstPostDateStruct': {'date': '2013-07-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Number of Decayed or Filled Permanent Teeth (DFT) From Baseline (Beginning of Kindergarten) to the Middle of 2nd Grade', 'timeFrame': 'baseline and middle of 2nd grade', 'description': 'The primary outcome measure was change in the number of decayed or filled permanent teeth (DFT). Caries was assessed in accordance to the International Caries Detection and Assessment System (ICDAS). The ICDAS criteria record both the severity and activity of the lesion on occlusal surfaces, in pit and fissure sites on the buccal and lingual surfaces, and on other smooth surfaces.\n\nFor the purposes of this study, an ICDAS severity score of 3 to 6 and the presence of fillings constituted the "D" and "F" portions of DFT, respectively.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dental Caries', 'Xylitol', 'Prevention'], 'conditions': ['Dental Caries']}, 'referencesModule': {'references': [{'pmid': '21916361', 'type': 'BACKGROUND', 'citation': 'Nelson S, Eggertsson H, Powell B, Mandelaris J, Ntragatakis M, Richardson T, Ferretti G. Dental examiners consistency in applying the ICDAS criteria for a caries prevention community trial. Community Dent Health. 2011 Sep;28(3):238-42.'}, {'pmid': '21986390', 'type': 'BACKGROUND', 'citation': 'Nelson S, Milgrom P. Minority participation in a school-based randomized clinical trial of tooth decay prevention in the United States. Contemp Clin Trials. 2012 Jan;33(1):60-6. doi: 10.1016/j.cct.2011.09.012. Epub 2011 Oct 1.'}, {'pmid': '22316214', 'type': 'BACKGROUND', 'citation': 'Nelson S, Mandelaris J, Ferretti G, Heima M, Spiekerman C, Milgrom P. School screening and parental reminders in increasing dental care for children in need: a retrospective cohort study. J Public Health Dent. 2012 Winter;72(1):45-52. doi: 10.1111/j.1752-7325.2011.00282.x. Epub 2011 Oct 10.'}]}, 'descriptionModule': {'briefSummary': 'The purposes of this study is to determine whether xylitol use in kindergarten school children in addition to oral health education, provision of tooth brush and fluoride paste, fluoride varnish and sealant treatment will reduce decay in the first permanent molars and other permanent teeth.', 'detailedDescription': 'This is a two group, 30 month randomized controlled clinical trial to assess, in conjunction with other primary preventive modalities, the use of xylitol gummy bears as snack food during school hours to reduce dental caries among children attending Kindergarten at the time of recruitment.\n\nClassrooms in five elementary schools were randomized to receive xylitol gummy bears or the control sugar-free (fiber) gummy bears. All gummy bears were formulated to be similar in size, consistency, color, and sweetness. They were in six bright colors attractive to children, and in strawberry and cherry flavors which are popular among children. Children were encouraged to chew the gummy bears slowly to maximize the xylitol exposure time in the mouth. The children received xylitol or placebo gummy bears throughout the 9 month kindergarten year, 3 times/day within the supervised school environment.\n\nIn addition to gummy bears, all participating children received oral health education, tooth brushing and fluoridated toothpaste, topical fluoride varnish treatment, and dental sealants when the first permanent molars have completely erupted. This design allows for the comparison between the current best recommended public heath practices and the addition of the new strategy, xylitol gummy bear snacks. Children were enrolled in kindergarten and followed until the middle of 2nd grade.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* attending kindergarten in one of the participating schools\n* must have parental permission\n\nExclusion Criteria:\n\n* children with severe stomach illness (ex. Crohn's disease, ulcerative colitis, Celiac disease, irritable bowel syndrome, etc.)\n* children with strict dietary restriction (ex. Diabetes)"}, 'identificationModule': {'nctId': 'NCT01901250', 'briefTitle': 'Xylitol for Caries Prevention in Inner-City Children', 'organization': {'class': 'OTHER', 'fullName': 'Case Western Reserve University'}, 'officialTitle': 'Xylitol for Caries Prevention in Inner-City Children', 'orgStudyIdInfo': {'id': '11-06-18'}, 'secondaryIdInfos': [{'id': 'R40MC07838', 'type': 'OTHER_GRANT', 'domain': 'HRSA/MCHB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Xylitol GB', 'description': 'Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant', 'interventionNames': ['Dietary Supplement: Xylitol gummy bears', 'Behavioral: Oral health education', 'Device: Fluoride varnish', 'Device: Dental sealant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Fiber GB', 'description': 'Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant', 'interventionNames': ['Dietary Supplement: Sugar free fiber gummy bears', 'Behavioral: Oral health education', 'Device: Fluoride varnish', 'Device: Dental sealant']}], 'interventions': [{'name': 'Xylitol gummy bears', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The children receive xylitol gummy bears 3 times/day within the supervised school environment.', 'armGroupLabels': ['Xylitol GB']}, {'name': 'Sugar free fiber gummy bears', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.', 'armGroupLabels': ['Fiber GB']}, {'name': 'Oral health education', 'type': 'BEHAVIORAL', 'description': 'Oral health education, toothbrush, and fluoride toothpaste', 'armGroupLabels': ['Fiber GB', 'Xylitol GB']}, {'name': 'Fluoride varnish', 'type': 'DEVICE', 'otherNames': ['Cavity Shield'], 'description': 'The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.', 'armGroupLabels': ['Fiber GB', 'Xylitol GB']}, {'name': 'Dental sealant', 'type': 'DEVICE', 'otherNames': ['UltraSeal XT plus'], 'description': 'The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted.', 'armGroupLabels': ['Fiber GB', 'Xylitol GB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Suchitra Nelson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Western Reserve University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Western Reserve University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Health Resources and Services Administration (HRSA)', 'class': 'FED'}, {'name': 'University of Washington', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Suchitra Nelson', 'investigatorAffiliation': 'Case Western Reserve University'}}}}