NCT03298620

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2013

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

1.6 years

First QC Date

September 26, 2017

Last Update Submit

September 29, 2017

Conditions

Keywords

nursing homegerodontologyoral hygiene

Outcome Measures

Primary Outcomes (1)

  • Change in dental plaque score by use of the Oral Hygiene Index- simplified (OHI-S)

    OHI-S is measuring amount of dental plaque using 6 indicator teeth. Outcome measure: change in OHI-S

    baseline, after 2 months, after 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Electric toothbrush

Other: Electric toothbrush

Control

ACTIVE COMPARATOR

New standard manual toothbrush

Other: Control

Interventions

Intervention
ControlOTHER

Manual toothbrush

Control

Eligibility Criteria

Age70 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients living in nursing home in Oslo
  • Provide written informed consent prior to enrolment (from relatives when patients were assessed by physician to be without ability to give written consent.

You may not qualify if:

  • Patients too weak to be examined
  • Patients With life expectancy less then one year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, 0317, Norway

Location

Related Publications (20)

  • 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: 18792846BACKGROUND
  • 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: 16433636BACKGROUND
  • 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: 16163906BACKGROUND
  • 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: 21564272BACKGROUND
  • 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: 15198386BACKGROUND
  • 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: 16677184BACKGROUND
  • 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: 15190692BACKGROUND
  • 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: 14076341BACKGROUND
  • 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: 10765880BACKGROUND
  • 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: 23433346BACKGROUND
  • 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: 17209777BACKGROUND
  • 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: 15001285BACKGROUND
  • 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: 15846633BACKGROUND
  • 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: 18700337BACKGROUND
  • 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: 22070521BACKGROUND
  • 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: 21815998BACKGROUND
  • 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: 19561578BACKGROUND
  • 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: 19780842BACKGROUND
  • 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: 19883892BACKGROUND
  • Marsh PD. Contemporary perspective on plaque control. Br Dent J. 2012 Jun 22;212(12):601-6. doi: 10.1038/sj.bdj.2012.524.

    PMID: 22722123BACKGROUND

Study Officials

  • Tiril Willumsen

    Institute of Clinical Odontology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 26, 2017

First Posted

October 2, 2017

Study Start

August 1, 2011

Primary Completion

February 28, 2013

Study Completion

December 15, 2016

Last Updated

October 2, 2017

Record last verified: 2017-09

Locations