Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT03298620
Status:
COMPLETED
Last Update Posted:
2017-10-02
First Post:
2017-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electric and Manual Toothbrushes in Nursing Homes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'A dental team (dentist and dental hygienist) assessed the outcome measure at baseline and after the two months RCT trial. A neutral dentist implements the intervention after baseline registration. Toothbrushes used in the intervention period is hidden to the dental team during assessments at the end of the RCT period.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 233}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-29', 'studyFirstSubmitDate': '2017-09-26', 'studyFirstSubmitQcDate': '2017-09-29', 'lastUpdatePostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in dental plaque score by use of the Oral Hygiene Index- simplified (OHI-S)', 'timeFrame': 'baseline, after 2 months, after 12 months', 'description': 'OHI-S is measuring amount of dental plaque using 6 indicator teeth. Outcome measure: change in OHI-S'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nursing home', 'gerodontology', 'oral hygiene'], 'conditions': ['Oral Health']}, 'referencesModule': {'references': [{'pmid': '18792846', 'type': 'BACKGROUND', 'citation': 'Samson H, Strand GV, Haugejorden O. Change in oral health status among the institutionalized Norwegian elderly over a period of 16 years. Acta Odontol Scand. 2008;66(6):368-73. doi: 10.1080/00016350802378654.'}, {'pmid': '16433636', 'type': 'BACKGROUND', 'citation': 'Meurman JH, Hamalainen P. Oral health and morbidity--implications of oral infections on the elderly. Gerodontology. 2006 Mar;23(1):3-16. doi: 10.1111/j.1741-2358.2006.00102.x.'}, {'pmid': '16163906', 'type': 'BACKGROUND', 'citation': 'Hamalainen P, Meurman JH, Kauppinen M, Keskinen M. Oral infections as predictors of mortality. Gerodontology. 2005 Sep;22(3):151-7. doi: 10.1111/j.1741-2358.2005.00064.x.'}, {'pmid': '21564272', 'type': 'BACKGROUND', 'citation': 'Zuluaga DJ, Ferreira J, Montoya JA, Willumsen T. Oral health in institutionalised elderly people in Oslo, Norway and its relationship with dependence and cognitive impairment. Gerodontology. 2012 Jun;29(2):e420-6. doi: 10.1111/j.1741-2358.2011.00490.x. Epub 2011 May 12.'}, {'pmid': '15198386', 'type': 'BACKGROUND', 'citation': 'Henriksen BM, Ambjornsen E, Axell T. Dental caries among the elderly in Norway. Acta Odontol Scand. 2004 Apr;62(2):75-81. doi: 10.1080/00016350310008580.'}, {'pmid': '16677184', 'type': 'BACKGROUND', 'citation': "Wolden H, Strand GV, Gjellestad A. Caregivers' perceptions of electric versus manual toothbrushes for the institutionalised elderly. Gerodontology. 2006 Jun;23(2):106-10. doi: 10.1111/j.1741-2358.2006.00114.x."}, {'pmid': '15190692', 'type': 'BACKGROUND', 'citation': "Forrest JL, Miller SA. Manual versus powered toothbrushes: a summary of the Cochrane Oral Health Group's Systematic Review. Part II. J Dent Hyg. 2004 Spring;78(2):349-54."}, {'pmid': '14076341', 'type': 'BACKGROUND', 'citation': 'GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. doi: 10.14219/jada.archive.1964.0034. No abstract available.'}, {'pmid': '10765880', 'type': 'BACKGROUND', 'citation': 'Henriksen BM, Ambjornsen E, Axell TE. Evaluation of a mucosal-plaque index (MPS) designed to assess oral care in groups of elderly. Spec Care Dentist. 1999 Jul-Aug;19(4):154-7. doi: 10.1111/j.1754-4505.1999.tb01378.x.'}, {'pmid': '23433346', 'type': 'BACKGROUND', 'citation': 'Lindqvist L, Seleskog B, Wardh I, von Bultzingslowen I. Oral care perspectives of professionals in nursing homes for the elderly. Int J Dent Hyg. 2013 Nov;11(4):298-305. doi: 10.1111/idh.12016. Epub 2013 Feb 25.'}, {'pmid': '17209777', 'type': 'BACKGROUND', 'citation': 'Robinson PG, Damien Walmsley A, Heanue M, Deacon S, Deery C, Glenny AM, Worthington H, Shaw W. Quality of trials in a systematic review of powered toothbrushes: suggestions for future clinical trials. J Periodontol. 2006 Dec;77(12):1944-53. doi: 10.1902/jop.2006.050349.'}, {'pmid': '15001285', 'type': 'BACKGROUND', 'citation': 'Deery C, Heanue M, Deacon S, Robinson PG, Walmsley AD, Worthington H, Shaw W, Glenny AM. The effectiveness of manual versus powered toothbrushes for dental health: a systematic review. J Dent. 2004 Mar;32(3):197-211. doi: 10.1016/j.jdent.2003.11.006.'}, {'pmid': '15846633', 'type': 'BACKGROUND', 'citation': 'Robinson PG, Deacon SA, Deery C, Heanue M, Walmsley AD, Worthington HV, Glenny AM, Shaw WC. Manual versus powered toothbrushing for oral health. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD002281. doi: 10.1002/14651858.CD002281.pub2.'}, {'pmid': '18700337', 'type': 'BACKGROUND', 'citation': "Hagman-Gustafsson ML, Holmen A, Stromberg E, Gabre P, Wardh I. Who cares for the oral health of dependent elderly and disabled persons living at home? A qualitative study of case managers' knowledge, attitudes and initiatives. Swed Dent J. 2008;32(2):95-104."}, {'pmid': '22070521', 'type': 'BACKGROUND', 'citation': 'Stromberg E, Hagman-Gustafsson ML, Holmen A, Wardh I, Gabre P. Oral status, oral hygiene habits and caries risk factors in home-dwelling elderly dependent on moderate or substantial supportive care for daily living. Community Dent Oral Epidemiol. 2012 Jun;40(3):221-9. doi: 10.1111/j.1600-0528.2011.00653.x. Epub 2011 Nov 9.'}, {'pmid': '21815998', 'type': 'BACKGROUND', 'citation': 'Philip P, Rogers C, Kruger E, Tennant M. Caries experience of institutionalized elderly and its association with dementia and functional status. Int J Dent Hyg. 2012 May;10(2):122-7. doi: 10.1111/j.1601-5037.2011.00525.x. Epub 2011 Aug 5.'}, {'pmid': '19561578', 'type': 'BACKGROUND', 'citation': 'Arpin S. Oral hygiene in elderly people in hospitals and nursing homes. Evid Based Dent. 2009;10(2):46. doi: 10.1038/sj.ebd.6400649.'}, {'pmid': '19780842', 'type': 'BACKGROUND', 'citation': 'Willumsen T, Fjaera B, Eide H. Oral health-related quality of life in patients receiving home-care nursing: associations with aspects of dental status and xerostomia. Gerodontology. 2010 Dec;27(4):251-7. doi: 10.1111/j.1741-2358.2009.00344.x.'}, {'pmid': '19883892', 'type': 'BACKGROUND', 'citation': 'Haumschild MS, Haumschild RJ. The importance of oral health in long-term care. J Am Med Dir Assoc. 2009 Nov;10(9):667-71. doi: 10.1016/j.jamda.2009.01.002. Epub 2009 Jun 28.'}, {'pmid': '22722123', 'type': 'BACKGROUND', 'citation': 'Marsh PD. Contemporary perspective on plaque control. Br Dent J. 2012 Jun 22;212(12):601-6. doi: 10.1038/sj.bdj.2012.524.'}]}, 'descriptionModule': {'briefSummary': 'Effect of electric toothbrush on oral hygiene in nursing home residents tested I randomized clinical trial for 2 months and followed up 12 months after baseline', 'detailedDescription': 'Patients in nursing homes often have many natural teeth with exposed root surfaces, bifurcations, a complexity of dental restorations like partial prostheses, bridges/crowns, fillings and implants. In addition they have a limited physical ability, like reduced muscular strength, rigidness in the neck and spine. All these factors contribute to make it difficult, both for themselves and their nursing staff to maintain good oral hygiene.\n\nElectrical toothbrushes have been proved effective in removal of dental plaque. There have also been reports from nursing homes that approves of electrical toothbrushes as a helpful aid among the nursing staff.\n\nThe present study examine if the overall oral hygiene actually improves with the use of electric toothbrush.\n\nMaterial and method: The study is a randomized clinical trial (RCT) that includes patients from nursing homes in Oslo. The recording dentist is blind to the type of tooth brush Inclusion criteria.\n\n* Patients living in nursing home in Oslo\n* Provide written informed consent prior to enrolment (from relatives when patients were assessed by physician to be without ability to give written consent.\n\nParticipants in the experimental group use an electrical toothbrush. Participants in the control group use a standard manual toothbrush.\n\nRegistration of oral hygiene and plaque score at baseline 0 and after 2 months intervention.\n\nAfter the RCT trial the participants were free to choose toothbrush, electric or manual. The study includes a follow-up study 10 months after the end of the RCT trial.\n\nThe study is a part of the PhD programme for Katrine Gahre Fjeld Cand. Odont.\n\nSupervisors:\n\nTiril Willumsen Dr Odont, The Dental Faculty, University of Oslo Hilde Eide Dr. Philos, Department of Nursing, Buskerud University College Morten Mowe Dr med, The Medical Faculty, University of Oslo'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients living in nursing home in Oslo\n* Provide written informed consent prior to enrolment (from relatives when patients were assessed by physician to be without ability to give written consent.\n\nExclusion Criteria:\n\n* Patients too weak to be examined\n* Patients With life expectancy less then one year'}, 'identificationModule': {'nctId': 'NCT03298620', 'briefTitle': 'Electric and Manual Toothbrushes in Nursing Homes', 'organization': {'class': 'OTHER', 'fullName': 'University of Oslo'}, 'officialTitle': 'Effect of Electric Toothbrush on Oral Hygiene in Nursing Home Residents- a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'REC-2011/915-5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Electric toothbrush', 'interventionNames': ['Other: Electric toothbrush']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'New standard manual toothbrush', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Electric toothbrush', 'type': 'OTHER', 'armGroupLabels': ['Intervention']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Manual toothbrush', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0317', 'city': 'Oslo', 'country': 'Norway', 'facility': 'University of Oslo', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Tiril Willumsen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Clinical Odontology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oslo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Tiril Willumsen', 'investigatorAffiliation': 'University of Oslo'}}}}