Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-04-08 @ 4:17 PM
Study NCT ID:
NCT01403805
Status:
COMPLETED
Last Update Posted:
2012-05-01
First Post:
2011-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of the Oral Care With Vaccines for Pneumonia in Elderly; Going Home Together Both Physician and Dentist
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'masahiro.hatta@hotmail.co.jp', 'phone': '+81-123-52-4339', 'title': 'Dr. Masahiro Hatta', 'organization': 'Department of Dentistry, Yubari Kibounomori, Japan'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'small numbers of subjects analyzed'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Died in Period from pneumonia', 'eventGroups': [{'id': 'EG000', 'title': 'Influenza Vaccine', 'description': 'Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).', 'otherNumAtRisk': 94, 'otherNumAffected': 0, 'seriousNumAtRisk': 94, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Oral Care With Influenza and Pneumococcal Vaccines', 'description': 'Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;\n\n1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material.', 'otherNumAtRisk': 105, 'otherNumAffected': 0, 'seriousNumAtRisk': 105, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Died in period', 'notes': '9 (4.5%) of the 199 eligible participants were death from pneumonia still in period.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Died before trial', 'notes': 'One participant was died before trial.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Pneumonia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine', 'description': 'Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).'}, {'id': 'OG001', 'title': 'Oral Care With Influenza and Pneumococcal Vaccines', 'description': 'Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;\n\n1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': "Fisher's test 'Vaccine' versus 'Oral Care and Vaccines' and 'phumonia' and 'not pneumonia'", 'groupDescription': "The results were analyzed as means ± standard deviation (SD) or numbers (%). Differences between the 2 nursing homes were compared using Fisher's test.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Number of Participants with Pneumonia sufferers', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Death From Pneumonia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine', 'description': 'Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).'}, {'id': 'OG001', 'title': 'Oral Care With Influenza and Pneumococcal Vaccines', 'description': 'Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;\n\n1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': "The results are expressed as means ± standard deviation (SD) or numbers (%). Differences between the 2 nursing homes were compared using Fisher's test.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Number of participants for the death from pneumonia', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Leaving Nursing Home', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Leaving Nursing Home', 'description': 'Numer of resident for leaving nursing home'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'These participants were followed for the duration of nursing home stay, an average of 22 weeks.', 'description': 'Numer of resident for leaving nursing home', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'These participants were determined as "Not Completed" due to "Leaving nursing home". We excluded these participants from analysis for outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Reject Oral Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Reject Oral Care', 'description': 'Number of resident to reject oral care'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'This participant rejected oral care before treatment, Day 1', 'description': 'Number of resident to reject oral care', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This participant was determined as "Not Completed" due to "Reject oral care". We excluded this participant from analysis for outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Reject Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Reject Vaccine', 'description': 'Number of resident to reject vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'These participants rejected vaccine before treatment, Day 1', 'description': 'Number of resident to reject vaccine', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'These participants were determined as "Not Completed" due to "Reject vaccine". We excluded these participants from analysis for outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Died Before Oral Care Starting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Died Before Oral Care Starting', 'description': 'Number of resident died before the start of oral care'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'This participant was died before treatment, Day 1', 'description': 'Number of resident died before the start of oral care', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This participant was determined as "Not Completed" due to "Died before oral care starting". We excluded this participant from analysis for outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Influenza Vaccine', 'description': 'Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).'}, {'id': 'FG001', 'title': 'Oral Care With Influenza and Pneumococcal Vaccines', 'description': 'Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;\n\n1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '105'}]}, {'type': 'Pneumonia Diagnosis', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Influenza Vaccine', 'description': 'Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).'}, {'id': 'BG001', 'title': 'Oral Care With Influenza and Pneumococcal Vaccines', 'description': 'Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;\n\n1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material.'}, {'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': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '85.0', 'spread': '7.48', 'groupId': 'BG000'}, {'value': '86.0', 'spread': '7.64', 'groupId': 'BG001'}, {'value': '85.5', 'spread': '7.56', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 199}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-29', 'studyFirstSubmitDate': '2011-07-25', 'resultsFirstSubmitDate': '2011-08-02', 'studyFirstSubmitQcDate': '2011-07-26', 'lastUpdatePostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-29', 'studyFirstPostDateStruct': {'date': '2011-07-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Leaving Nursing Home', 'timeFrame': 'These participants were followed for the duration of nursing home stay, an average of 22 weeks.', 'description': 'Numer of resident for leaving nursing home'}, {'measure': 'Reject Oral Care', 'timeFrame': 'This participant rejected oral care before treatment, Day 1', 'description': 'Number of resident to reject oral care'}, {'measure': 'Reject Vaccine', 'timeFrame': 'These participants rejected vaccine before treatment, Day 1', 'description': 'Number of resident to reject vaccine'}, {'measure': 'Died Before Oral Care Starting', 'timeFrame': 'This participant was died before treatment, Day 1', 'description': 'Number of resident died before the start of oral care'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Pneumonia', 'timeFrame': '1 year', 'description': 'Number of Participants with Pneumonia sufferers'}], 'secondaryOutcomes': [{'measure': 'Death From Pneumonia', 'timeFrame': '1 year', 'description': 'Number of participants for the death from pneumonia'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Oral care', 'Vaccine', 'Pneumonia', 'Elderly', 'Prevention', 'Primary care'], 'conditions': ['Pneumonia']}, 'descriptionModule': {'briefSummary': 'Prospective study comparing the effects of interventions (combined oral care and pneumococcal plus influenza vaccinations) in preventing pneumonia and increasing the survival rate from pneumonia.', 'detailedDescription': 'The elderly population can be expected to increase not only in developed countries, but also in developing countries. Pneumonia is one of the most common causes of death in the elderly.\n\nThe investigators conducted a prospective study comparing the effects of interventions (combined oral care and pneumococcal plus influenza vaccinations) in preventing pneumonia and increasing the survival rate from pneumonia in consecutive elderly patients at a nursing home in Yubari during one year from 2009, with the results in a non-intervention group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The residents or an agent who understand the purpose of this study and give informed consent.\n\nExclusion Criteria:\n\n* The residents contraindicated to vaccine'}, 'identificationModule': {'nctId': 'NCT01403805', 'briefTitle': 'Effects of the Oral Care With Vaccines for Pneumonia in Elderly; Going Home Together Both Physician and Dentist', 'organization': {'class': 'OTHER', 'fullName': 'Yubari Kibounomori'}, 'officialTitle': 'The Interventional Study in the Effects of Oral Care With Vaccines at Nursing Home; the Role of the Partnership With Physician, Dentist and Other Co-medical Stuff', 'orgStudyIdInfo': {'id': '803121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral care and vaccines', 'description': 'Oral care and pneumococcal plus influenza vaccines', 'interventionNames': ['Biological: Pneumococcal vaccination (Pneumovax NP, 21800AMY10131000)', 'Biological: Influenza vaccination (Flubik HA, 16100EZZ01207000)', 'Other: Specific frequency of oral care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vaccine', 'description': 'Influenza vaccine only', 'interventionNames': ['Biological: Influenza vaccination (Flubik HA, 16100EZZ01207000)']}], 'interventions': [{'name': 'Pneumococcal vaccination (Pneumovax NP, 21800AMY10131000)', 'type': 'BIOLOGICAL', 'otherNames': ['Pneumovax NP', 'Serial Number: 21800AMY10131000'], 'description': 'Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day', 'armGroupLabels': ['Oral care and vaccines']}, {'name': 'Influenza vaccination (Flubik HA, 16100EZZ01207000)', 'type': 'BIOLOGICAL', 'otherNames': ['Flubik HA', 'Serial Number: 16100EZZ01207000'], 'description': 'Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day', 'armGroupLabels': ['Oral care and vaccines']}, {'name': 'Influenza vaccination (Flubik HA, 16100EZZ01207000)', 'type': 'BIOLOGICAL', 'otherNames': ['Flubik HA', 'Serial Number: 16100EZZ01207000'], 'description': 'Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day', 'armGroupLabels': ['Vaccine']}, {'name': 'Specific frequency of oral care', 'type': 'OTHER', 'otherNames': ['Not applicable:Behaviour'], 'description': '1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room primary care physicians. At the same time, they taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material.', 'armGroupLabels': ['Oral care and vaccines']}]}, 'contactsLocationsModule': {'locations': [{'zip': '068-0402', 'city': 'Yūbari', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Yubari Kibounomori', 'geoPoint': {'lat': 43.03778, 'lon': 141.95778}}], 'overallOfficials': [{'name': 'Hirofumi Hashimoto, M.D.,Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yubari Health Care Research Center'}, {'name': 'Masahiro Hatta, D.D.S.', 'role': 'STUDY_CHAIR', 'affiliation': 'Yubari Kibounomori'}, {'name': 'Takahiro Ichiki, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mukawa town National Health Insurance Hobetsu clinic'}, {'name': 'Katsushi Nagamori, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yubari Health Care Research Center'}, {'name': 'Hiroyuki Morita, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yubari Health Care Research Cente'}, {'name': 'Masako Hatta, D.D.S.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yubari Health Care Research Center'}, {'name': 'Tomohiko Murakami, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yubari Kibounomori'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yubari Kibounomori', 'class': 'OTHER'}, 'collaborators': [{'name': 'Health Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Masahiro Hatta', 'investigatorAffiliation': 'Yubari Kibounomori'}}}}