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

Sponsor
University of Manitoba (Other)
Overall Status
Completed
CT.gov ID
NCT01639183
Collaborator
Canadian Foundation for Dental Hygiene Research and Education (Other)
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Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: Rotating-oscillating Power Toothbrush
  • Other: Standard Care
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (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
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Caregiver Compliance [6 weeks]

      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.

    2. Systemic Inflammation [6 weeks]

      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.

    3. Oral Inflammation [6 weeks]

      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

    1. Oral Plaque on Teeth [6 weeks]

      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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Salme E. Lavigne, Professor, University of Manitoba
    ClinicalTrials.gov Identifier:
    NCT01639183
    Other Study ID Numbers:
    • H2012:227
    First Posted:
    Jul 12, 2012
    Last Update Posted:
    Jul 24, 2013
    Last Verified:
    Jul 1, 2013
    Keywords provided by Salme E. Lavigne, Professor, University of Manitoba
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 24, 2013