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NCT03298620 Clinical Trial

Electric and Manual Toothbrushes in Nursing Homes

Oral Health Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03298620
Other study ID # REC-2011/915-5
Secondary ID
Status Completed
Phase N/A
First received September 26, 2017
Last updated September 29, 2017
Start date August 1, 2011
Est. completion date December 15, 2016

Study information
Verified date September 2017
Source University of Oslo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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

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

Recruitment information / eligibility
Status Completed
Enrollment 233
Est. completion date December 15, 2016
Est. primary completion date February 28, 2013
Accepts healthy volunteers No
Gender All
Age group 70 Years to 105 Years
Eligibility 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.

Exclusion Criteria:

- Patients too weak to be examined

- Patients With life expectancy less then one year

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Electric toothbrush

• Control
Manual toothbrush

Locations
Country Name City State
Norway University of Oslo Oslo

Sponsors (1)
Lead Sponsor Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

References & Publications (20)

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. — View 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. Review. — View 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. — View Citation

GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. — View Citation

Hagman-Gustafsson ML, Holmén A, Strömberg E, Gabre P, Wårdh 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. — View Citation

Hämäläinen P, Meurman JH, Kauppinen M, Keskinen M. Oral infections as predictors of mortality. Gerodontology. 2005 Sep;22(3):151-7. — View 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. Review. — View Citation

Henriksen BM, Ambjørnsen E, Axéll T. Dental caries among the elderly in Norway. Acta Odontol Scand. 2004 Apr;62(2):75-81. — View Citation

Henriksen BM, Ambjørnsen E, Axéll 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. — View Citation

Lindqvist L, Seleskog B, Wårdh I, von Bültzingslöwen 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. — View 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. Review. — View Citation

Meurman JH, Hämäläinen P. Oral health and morbidity--implications of oral infections on the elderly. Gerodontology. 2006 Mar;23(1):3-16. Review. — View 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. — View 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. Review. — View 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. Review. Update in: Cochrane Database Syst Rev. 2014;6:CD002281. — View 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. — View Citation

Strömberg E, Hagman-Gustafsson ML, Holmén A, Wårdh 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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