Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2026-02-20 @ 5:57 PM
Study NCT ID:
NCT02647203
Status:
COMPLETED
Last Update Posted:
2024-01-02
First Post:
2015-12-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-invasive Treatment of Root Caries in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017213', 'term': 'Root Caries'}], 'ancestors': [{'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014099', 'term': 'Toothbrushing'}], 'ancestors': [{'id': 'D009910', 'term': 'Oral Hygiene'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'giacaman@utalca.cl', 'phone': '+56712201546', 'title': 'Dr. Rodrigo Giacaman', 'phoneExt': '2654', 'organization': 'University of Talca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 years', 'description': 'Burning feeling, irritation or feeling the mouth uncomfortably are the only potential adverse effects, due to the dentifrices used.\n\nAll-Cause Mortality was monitored/assessed', 'eventGroups': [{'id': 'EG000', 'title': 'High Fluoride Toothpaste', 'description': '5,000 ppm fluoridated toothpaste, high concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)\n\nSelf-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.', 'otherNumAtRisk': 142, 'deathsNumAtRisk': 142, 'otherNumAffected': 0, 'seriousNumAtRisk': 142, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Fluoride Toothpaste', 'description': '1,450 ppm fluoridated toothpaste, low concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)\n\nSelf-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.', 'otherNumAtRisk': 138, 'deathsNumAtRisk': 138, 'otherNumAffected': 0, 'seriousNumAtRisk': 138, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Root Caries Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Fluoride Toothpaste', 'description': '5,000 ppm fluoridated toothpaste, high concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)\n\nSelf-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.'}, {'id': 'OG001', 'title': 'Standard Fluoride Toothpaste', 'description': '1,450 ppm fluoridated toothpaste, low concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)\n\nSelf-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.72', 'spread': '12.32', 'groupId': 'OG000'}, {'value': '40.52', 'spread': '23.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 2 years of follow up', 'description': "Using Nyvad's criteria for root caries lesions, activity will be assessed by a visual-tactile method.", 'unitOfMeasure': 'Percentage of active lesions (2-years)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Independently-living older adults'}, {'type': 'SECONDARY', 'title': 'Oral Health Related Quality of Life, Measured by the Oral Health Impact Profile (OHIP-14 Sp)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Fluoride Toothpaste', 'description': '5,000 ppm fluoridated toothpaste, high concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)\n\nSelf-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.'}, {'id': 'OG001', 'title': 'Standard Fluoride Toothpaste', 'description': '1,450 ppm fluoridated toothpaste, low concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)\n\nSelf-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.71', 'spread': '9.56', 'groupId': 'OG000'}, {'value': '11.28', 'spread': '9.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data registered at 2 years of follow-up', 'description': 'The impact on the quality of life of the therapy will be explored using the OHIP-14 Sp, validated by our group. In a scale ranging from 0 to 56 points, with 0-14 being good Oral Health-related quality of life and 15-56 poor Oral Health-related quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Independently-living older adults'}, {'type': 'SECONDARY', 'title': 'Salivary Flow', 'timeFrame': 'Baseline and 2-year follow up', 'description': 'Unstimulated Salivary Flow, defined as Normal or Low Important: This outcome measure was originally considered. However, due to logistic issues, we did not assess it and no data is available.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Fluoride Toothpaste', 'description': '5,000 ppm fluoridated toothpaste, high concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)\n\nSelf-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.'}, {'id': 'FG001', 'title': 'Standard Fluoride Toothpaste', 'description': '1,450 ppm fluoridated toothpaste, low concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)\n\nSelf-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.'}], 'periods': [{'title': '12 Month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '172'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '23'}]}]}, {'title': '24 Month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '138'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'High Fluoride Toothpaste', 'description': '5,000 ppm fluoridated toothpaste, high concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)\n\nSelf-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.'}, {'id': 'BG001', 'title': 'Standard Fluoride Toothpaste', 'description': '1,450 ppm fluoridated toothpaste, low concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)\n\nSelf-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '173', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '258', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Socioeconomic status', 'classes': [{'categories': [{'title': 'Upper', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}, {'title': 'Lower', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'categories': [{'title': 'Less or equal than 8 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'title': '9 - 12 years', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}, {'title': 'More than 12 years', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 345}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-28', 'studyFirstSubmitDate': '2015-12-07', 'resultsFirstSubmitDate': '2018-11-03', 'studyFirstSubmitQcDate': '2016-01-05', 'lastUpdatePostDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-09', 'studyFirstPostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Root Caries Activity', 'timeFrame': 'After 2 years of follow up', 'description': "Using Nyvad's criteria for root caries lesions, activity will be assessed by a visual-tactile method."}], 'secondaryOutcomes': [{'measure': 'Oral Health Related Quality of Life, Measured by the Oral Health Impact Profile (OHIP-14 Sp)', 'timeFrame': 'Data registered at 2 years of follow-up', 'description': 'The impact on the quality of life of the therapy will be explored using the OHIP-14 Sp, validated by our group. In a scale ranging from 0 to 56 points, with 0-14 being good Oral Health-related quality of life and 15-56 poor Oral Health-related quality of life.'}, {'measure': 'Salivary Flow', 'timeFrame': 'Baseline and 2-year follow up', 'description': 'Unstimulated Salivary Flow, defined as Normal or Low Important: This outcome measure was originally considered. However, due to logistic issues, we did not assess it and no data is available.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fluoride toothpaste', 'Root caries', 'Randomized clinical trial'], 'conditions': ['Root Caries']}, 'referencesModule': {'references': [{'pmid': '18194330', 'type': 'BACKGROUND', 'citation': 'Ekstrand K, Martignon S, Holm-Pedersen P. Development and evaluation of two root caries controlling programmes for home-based frail people older than 75 years. Gerodontology. 2008 Jun;25(2):67-75. doi: 10.1111/j.1741-2358.2007.00200.x. Epub 2008 Jan 13.'}, {'pmid': '23594784', 'type': 'BACKGROUND', 'citation': 'Ekstrand KR, Poulsen JE, Hede B, Twetman S, Qvist V, Ellwood RP. A randomized clinical trial of the anti-caries efficacy of 5,000 compared to 1,450 ppm fluoridated toothpaste on root caries lesions in elderly disabled nursing home residents. Caries Res. 2013;47(5):391-8. doi: 10.1159/000348581. Epub 2013 Apr 9.'}, {'pmid': '23600985', 'type': 'BACKGROUND', 'citation': 'Gluzman R, Katz RV, Frey BJ, McGowan R. Prevention of root caries: a literature review of primary and secondary preventive agents. Spec Care Dentist. 2013 May-Jun;33(3):133-40. doi: 10.1111/j.1754-4505.2012.00318.x. Epub 2012 Dec 10.'}, {'pmid': '15271973', 'type': 'BACKGROUND', 'citation': 'Griffin SO, Griffin PM, Swann JL, Zlobin N. Estimating rates of new root caries in older adults. J Dent Res. 2004 Aug;83(8):634-8. doi: 10.1177/154405910408300810.'}, {'pmid': '17452559', 'type': 'BACKGROUND', 'citation': 'Griffin SO, Regnier E, Griffin PM, Huntley V. Effectiveness of fluoride in preventing caries in adults. J Dent Res. 2007 May;86(5):410-5. doi: 10.1177/154405910708600504.'}, {'pmid': '24603245', 'type': 'BACKGROUND', 'citation': 'Holmgren C, Gaucher C, Decerle N, Domejean S. Minimal intervention dentistry II: part 3. Management of non-cavitated (initial) occlusal caries lesions--non-invasive approaches through remineralisation and therapeutic sealants. Br Dent J. 2014 Mar;216(5):237-43. doi: 10.1038/sj.bdj.2014.147.'}, {'pmid': '20545716', 'type': 'BACKGROUND', 'citation': 'Ritter AV, Shugars DA, Bader JD. Root caries risk indicators: a systematic review of risk models. Community Dent Oral Epidemiol. 2010 Oct;38(5):383-97. doi: 10.1111/j.1600-0528.2010.00551.x.'}, {'pmid': '22899677', 'type': 'BACKGROUND', 'citation': 'Walls AW, Meurman JH. Approaches to caries prevention and therapy in the elderly. Adv Dent Res. 2012 Sep;24(2):36-40. doi: 10.1177/0022034512453590.'}, {'pmid': '25091189', 'type': 'RESULT', 'citation': 'Leon S, Bravo-Cavicchioli D, Correa-Beltran G, Giacaman RA. Validation of the Spanish version of the Oral Health Impact Profile (OHIP-14Sp) in elderly Chileans. BMC Oral Health. 2014 Aug 4;14:95. doi: 10.1186/1472-6831-14-95.'}, {'pmid': '31176788', 'type': 'DERIVED', 'citation': 'Leon S, Gonzalez K, Hugo FN, Gambetta-Tessini K, Giacaman RA. High fluoride dentifrice for preventing and arresting root caries in community-dwelling older adults: A randomized controlled clinical trial. J Dent. 2019 Jul;86:110-117. doi: 10.1016/j.jdent.2019.06.002. Epub 2019 Jun 6.'}], 'seeAlsoLinks': [{'url': 'https://repositorio.cepal.org/bitstream/handle/11362/7118/1/S2012922_mu.pdf', 'label': 'CEPAL (2013). Observatorio demográfico 2012. Proyecciones de población'}, {'url': 'http://www.ons.gov.uk/ons/rel/npp/national-population-projections/2012-based-projections/stb-2012-based-npp-principal-and-key-variants.html', 'label': 'ONS (2013). Statistical bulletin: National Population Projections, 2012-based Statistical Bulletin'}]}, 'descriptionModule': {'briefSummary': 'This study aims to test the effectiveness in reducing or arresting root caries lesion in community-dwelling elderly subjects by using high fluoridated toothpaste. A double blinded RCT will be conducted with two arms; 5000 ppm F and 1450 ppm F toothpaste. Dentifrices will be delivered to the participants in a blind format and they will be instructed to brush twice per day.\n\nFollow-up will be carries out every 6 months for two years to assess:\n\n* Root caries incidence.\n* Lesion arresting\n* Changes in salivary flow\n* Microbiology pattern shift\n* Variations in oral health- related quality of life by OHIP-14 Sp', 'detailedDescription': 'Background. Caries of the root surface (root caries) is the most prevalent type of dental caries in older adults with a reportedly worrisome trend to increase, as more teeth are being retained. Dental caries is the leading causes of tooth loss among older adults. Fluoride has been successfully used in preventive programs for root caries. In addition to preventing root caries, fluoride-based therapies may be used to treat lesions. This approach is known as non-invasive treatment. Fluoride seems to arrest and promote remineralization of the lesions. Indeed, recent studies appear to indicate that, higher fluoride concentrations are more effective to prevent and to treat the disease. Dentifrices with high concentrations of fluoride appear to be the most rational approach to prevent and treat root caries. To the chemical effect of fluoride, toothbrushing adds mechanical removal of the dental biofilm. High concentration fluoride varnishes have also been proposed as effective in treating carious lesions. Whether dentifrices, varnishes or the combined use of varnish and fluoridated toothpaste result more effective is a matter of controversy and it needs to be elucidated. Non-invasive treatment avoids the complications inherent to treating frail people in a dental setting, decrease costs and importantly, allows increased coverage, as these therapies may be delivered by non-dentist personnel. Although the appealing idea of non-invasive treatment of root caries in older adults, evidence is still limited and more research appears necessary to both, confirm clinical success and elucidate the mechanisms involved in lesion arrestment.\n\nAim. To determine the effectiveness of non-invasive therapies for root caries and their impact in the quality of life of older adults.\n\nMethodology. A double blind randomized controlled trial (RCT) on independently-living older adults aged sixty or more years is proposed. Subjects will undergo clinical and microbiological examination when recruited (baseline) with a six-month follow-up regime until completion of two years. To participate, subjects will have to have at least five teeth with exposed root surfaces and one carious lesion. Sample size was calculated and a sample of two-hundred and eighty-eight older adults is necessary, randomized into two study arms;\n\nGroup 1: toothpaste 1.450 ppm F-\n\nGroup 2: toothpaste 5.000 ppm F-\n\nDependent variables. Root caries incidence and activity, cariogenic bacteria and oral health-related quality of life will be assessed upon completion of the study and compared with baseline scores.\n\nExpected results. Based on some previous data available, it is expected that a non-invasive therapy for root caries based on low-fluoride concentration will be less effective than high fluoride therapies in inactivating root caries lesions. These results may be used in novel therapeutic programs at the community level, as well as in private practice. Furthermore, these studies will shed light on potential mechanisms associated with non-invasive treatment of root caries, from a microbiology stand point. Since a non-invasive approach decreases costs and increases coverage of dental care for older adults, these results may contribute to increase access to care for the usually vulnerable population of older adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 60 + years old\n* community-dwelling\n* living in a community with fluoridated water\n* had five or more of their own teeth\n* with ≥ 1 root caries lesion\n\nExclusion Criteria:\n\n* cognitive impairment\n* alcoholism'}, 'identificationModule': {'nctId': 'NCT02647203', 'acronym': 'MIT-RCTalca', 'briefTitle': 'Non-invasive Treatment of Root Caries in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Talca'}, 'officialTitle': 'Non-invasive Therapy With Fluoridated Toothpastes for Root Caries in Independently-living Older Adults', 'orgStudyIdInfo': {'id': 'NI-RC PIEI-ES'}, 'secondaryIdInfos': [{'id': '1140623', 'type': 'OTHER_GRANT', 'domain': 'Fondecyt - Conicyt Chile'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Fluoride Toothpaste', 'description': '5,000 ppm fluoridated toothpaste, high concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)', 'interventionNames': ['Drug: Self-administered fluoridated dentifrices']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Fluoride Toothpaste', 'description': '1,450 ppm fluoridated toothpaste, low concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)', 'interventionNames': ['Drug: Self-administered fluoridated dentifrices']}], 'interventions': [{'name': 'Self-administered fluoridated dentifrices', 'type': 'DRUG', 'otherNames': ['Toothbrushing with high and standard fluoride dentifrices'], 'description': 'Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.', 'armGroupLabels': ['High Fluoride Toothpaste', 'Standard Fluoride Toothpaste']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3460000', 'city': 'Talca', 'state': 'No State', 'country': 'Chile', 'facility': 'Faculty of Health Sciences', 'geoPoint': {'lat': -35.4232, 'lon': -71.64974}}], 'overallOfficials': [{'name': 'Rodrigo A Giacaman, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Talca'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Talca', 'class': 'OTHER'}, 'collaborators': [{'name': 'Federal University of Rio Grande do Sul', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Rodrigo A. Giacaman, DDS, PhD', 'investigatorAffiliation': 'University of Talca'}}}}