Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-30 @ 8:10 PM
Study NCT ID:
NCT01578603
Status:
COMPLETED
Last Update Posted:
2012-05-10
First Post:
2012-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Two Sugar Substituted Chewing Gums on Caries and Gingivitis Variables
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003773', 'term': 'Dental Plaque'}, {'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014993', 'term': 'Xylitol'}, {'id': 'D013402', 'term': 'Sugar Alcohols'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-09', 'studyFirstSubmitDate': '2012-04-09', 'studyFirstSubmitQcDate': '2012-04-14', 'lastUpdatePostDateStruct': {'date': '2012-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Turesky index', 'timeFrame': 'a month', 'description': 'dental plaque assessment'}], 'secondaryOutcomes': [{'measure': 'Gingival index', 'timeFrame': 'a month', 'description': 'gingival inflammation'}, {'measure': 'salivary pH', 'timeFrame': 'a month'}, {'measure': 'Streptococcus mutans', 'timeFrame': 'a month', 'description': 'number of Streptococcus mutans in saliva'}, {'measure': 'Ca levels', 'timeFrame': 'a month', 'description': 'levels of calcium in saliva'}, {'measure': 'facultative microorganisms', 'timeFrame': 'a month', 'description': 'number of facultative microorganisms in saliva'}, {'measure': 'Lactobacillus', 'timeFrame': 'a month', 'description': 'levels of Lactobacillus spp. in saliva'}, {'measure': 'phosphate levels', 'timeFrame': 'a month', 'description': 'inorganic phosphate leves in saliva'}, {'measure': 'BOP index', 'timeFrame': 'a month', 'description': 'bleeding on probing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prevention & control', 'Xylitol', 'casein phosphopeptide amorphous calcium phosphate complex', 'Streptococcus mutans', 'saliva', 'dental plaque', 'gingivitis'], 'conditions': ['Dental Plaque', 'Saliva Altered', 'Gingivitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of three times a day mastication, during a follow-up period of 4 weeks, of two sugar-substituted chewing gums on various factors associated with dental caries and gingivitis.', 'detailedDescription': 'The purpose of this paper is to compare the effect of daily consumption of two sugar-free chewing gum, one with Recaldent and one with Xylitol, added to traditional hygiene (brushing, fluoridated toothpaste and dental floss), in clinical features such as the accumulation of plaque and gingival inflammation, microbiological characteristics of saliva as the counts of cariogenic microorganisms and facultative anaerobes, and some physicochemical properties of saliva such as pH and concentrations of calcium and inorganic phosphate.\n\nTo this there was a general call among dental students at the University of Antioquia and those who expressed their intention to participate voluntarily with informed consent, were examined clinically and randomly assigned to one of the study groups (Recaldent or Xylitol) or the control group.\n\nAfter a month of baseline examination and the daily use of the same instruments of oral hygiene and chewing of 6 pellets of each chewing gum (in the case of study groups), all variables are re-examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '34 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* systemically healthy\n* dental student\n\nExclusion Criteria:\n\n* less than 26 teeth in mouth\n* use of orthodontic appliances\n* use of antibiotics the last 3 months'}, 'identificationModule': {'nctId': 'NCT01578603', 'briefTitle': 'Effects of Two Sugar Substituted Chewing Gums on Caries and Gingivitis Variables', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Antioquia'}, 'officialTitle': 'Effects of Two Sugar Substituted Chewing Gums Plus Tooth Brushing on Different Caries and Gingivitis Related Variables: a Double Blind, Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '15-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sugar substituted chewing gum A', 'interventionNames': ['Dietary Supplement: casein phosphopeptide amorphous calcium phosphate complex']}, {'type': 'EXPERIMENTAL', 'label': 'Sugar substituted chewing gum B', 'interventionNames': ['Dietary Supplement: xylitol']}], 'interventions': [{'name': 'xylitol', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['sugar alcohol'], 'description': '6 g/day, for a month, by chewing 2g three times daily after meals.', 'armGroupLabels': ['Sugar substituted chewing gum B']}, {'name': 'casein phosphopeptide amorphous calcium phosphate complex', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['CPP-ACP complex'], 'description': 'two pieces of the commercial presentation three times daily after meals', 'armGroupLabels': ['sugar substituted chewing gum A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Medellín', 'state': 'Antioquia', 'country': 'Colombia', 'facility': 'Facultad de Odontología, Universidad de Antioquia', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}], 'overallOfficials': [{'name': 'Maria C Martínez-Pabón, MsC Microb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad de Antioquia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Antioquia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Profesora Asociada', 'investigatorFullName': 'María Cecilia Martínez-Pabón', 'investigatorAffiliation': 'Universidad de Antioquia'}}}}