Power Toothbrush Use in Nursing Homes to Eliminate Mouth and Body Inflammation

This study has been completed.
Sponsor:
Collaborator:
Canadian Foundation for Dental Hygiene Research and Education
Information provided by (Responsible Party):
Salme E. Lavigne, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01639183
First received: July 10, 2012
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to investigate whether brushing the teeth of nursing home residents with a power toothbrush as compared with standard care typically provided in nursing homes, will increase caregiver compliance with the provision of daily oral care as well as lower oral and systemic inflammation.


Condition Intervention
Periodontal Disease
Device: Rotating-oscillating Power Toothbrush
Other: Standard Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Daily Power Toothbrushing on Caregiver Compliance and on Oral and Systemic Inflammation in a Nursing Home Population: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Caregiver Compliance [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Compliance with power toothbrushing vs standard oral hygiene care will be measured by means of a wall chart filled out by caregivers in the residents rooms.

  • Systemic Inflammation [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Systemic inflammation will be measured using a high sensitivity C-reactive protein test (hsCRP. Blood will be drawn at baseline and at 6 weeks to facilitate this test for both intervention and control groups.

  • Oral Inflammation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    Oral inflammation will be measured at baseline and 6 weeks by means of 2 tests:

    The Modified Gingival Index (Lobene, 1979) and the Papillary Bleeding Score (Loesche, 1989)



Secondary Outcome Measures:
  • Oral Plaque on Teeth [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Changes in plaque accumulation on the teeth for both intervention and control groups will be measured using The Turesky Modification (1970) of the Quigley & Hein Plaque Index (1962)


Enrollment: 58
Study Start Date: September 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rotating-oscillating Power Toothbrush
Nursing home residents will be randomly assigned to receive power toothbrushing twice daily by their caregivers using a rotating-oscillating power toothbrush.
Device: Rotating-oscillating Power Toothbrush
A power toothbrush will be used twice daily for performing daily oral care on nursing home residents by their caregivers.
Other Name: Oral-B Professional series 5000 (Proctor & Gamble Co.)
Active Comparator: Standard Care
This arm comprises the control group where nursing home residents will receive standard daily oral care as usual.
Other: Standard Care
Standard daily oral hygiene care by caregivers of nursing home residents whatever that standard care may be.

Detailed Description:

It is well recognized worldwide that residents of nursing homes have poor oral health primarily due to caregiver resistance in the provision of daily oral hygiene care. Fear of being bitten or assaulted by the resident as well as lack of time and discomfort with working in the mouth, are reasons cited for this resistance. It is also now recognized that inflammation in the mouth can raise overall inflammation within the body potentially leading to serious health consequences. Numerous studies involving periodic professional interventions as well as education and training of caregivers in oral care provision have not met with a great deal of success. Caregivers in some studies have indicated preference to power toothbrushes as they are bulkier and longer eliminating the need for insertion of fingers into the mouth and subsequently alleviating fears of being bitten. This study hypothesizes that caregiver utilization of a power toothbrush may increase their compliance with daily oral care provision and could potentially result in elimination of oral and systemic inflammation.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Residents of Nursing Home
  • Presence of any natural teeth
  • Non-aggressive behavior
  • Presence of Periodontal inflammation

Exclusion Criteria:

  • Smoking
  • Comatose
  • On a ventilator
  • Aggressive behavior
  • Presence of communicable disease
  • On antibiotics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01639183

Locations
Canada, Manitoba
Deer Lodge Centre
Winnipeg, Manitoba, Canada, R3J 0L3
Sponsors and Collaborators
University of Manitoba
Canadian Foundation for Dental Hygiene Research and Education
Investigators
Principal Investigator: Salme E Lavigne, MS University of Manitoba
  More Information

No publications provided

Responsible Party: Salme E. Lavigne, Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT01639183     History of Changes
Other Study ID Numbers: H2012:227
Study First Received: July 10, 2012
Last Updated: July 23, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
oral inflammation
systemic inflammation
compliance
power toothbrushing
nursing home residents

Additional relevant MeSH terms:
Inflammation
Periodontal Diseases
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on April 22, 2014