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Oral HealthNCT03298620

Electric and Manual Toothbrushes in Nursing Homes

A study testing Electric toothbrush in people with Oral Health, run by University of Oslo at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 70 to 105 years
Conditions the study is for
Oral Health
What is being tested?
Electric toothbrush
Could I receive a placebo?
No, everyone receives an active treatment
How many people
233 participants
Where
1 siteNorway
Study dates
1 Aug 2011to 15 Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 to 105 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • University of Oslo

    Oslo, 0317

Other trials in Norway

About this study

Official title: Effect of Electric Toothbrush on Oral Hygiene in Nursing Home Residents- a Randomized Clinical Trial

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

Read the detailed description

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.

Electrical 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.

The present study examine if the overall oral hygiene actually improves with the use of electric toothbrush.

Material 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.

  • 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.

Participants in the experimental group use an electrical toothbrush. Participants in the control group use a standard manual toothbrush.

Registration of oral hygiene and plaque score at baseline 0 and after 2 months intervention.

After 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.

The study is a part of the PhD programme for Katrine Gahre Fjeld Cand. Odont.

Supervisors:

Tiril 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

Conditions
Oral Health
Being tested
Electric toothbrush, Control
Keywords
nursing home, gerodontology, oral hygiene

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electric toothbrushOther

  • ControlOther

    Manual toothbrush

Study groups in NCT03298620
Study groupRoleWhat they receive
InterventionExperimentalElectric toothbrush
Receives: Other: Electric toothbrush
ControlActive comparatorNew standard manual toothbrush
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: baseline, after 2 months, after 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2017
  2. Study start1 Aug 2011
  3. Primary completion28 Feb 2013
  4. Study completion15 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Clinical trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
233 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03298620
Sponsor's protocol ID
REC-2011/915-5
Status last verified
Sep 2017
First submitted
26 Sep 2017
Last updated
2 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 18792846

  • 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.

    PubMed 16433636

  • 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.

    PubMed 16163906

  • 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.

    PubMed 21564272

  • 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.

    PubMed 15198386

  • 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.

    PubMed 16677184

  • 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.

    PubMed 15190692

  • 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.

    PubMed 14076341

  • 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.

    PubMed 10765880

  • 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.

    PubMed 23433346

  • 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.

    PubMed 17209777

  • 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.

    PubMed 15001285

  • 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.

    PubMed 15846633

  • 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.

    PubMed 18700337

  • 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.

    PubMed 22070521

Questions about this trial

What is this clinical trial studying?

A study testing Electric toothbrush in people with Oral Health, run by University of Oslo at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in dental plaque score by use of the Oral Hygiene Index- simplified (OHI-S) (time frame: baseline, after 2 months, after 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03298620, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.

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