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Completed

NCT Number: NCT01639183

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Deer Lodge Centre

Winnipeg, Manitoba, R3J 0L3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rotating-oscillating Power Toothbrush

Device

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.)

Standard care

Other

Standard daily oral hygiene care by caregivers of nursing home residents whatever that standard care may be.

Primary outcomes

  1. Caregiver Compliance

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Oral Plaque on Teeth

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Canadian Foundation for Dental Hygiene Research and Education

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 12, 2012
Registry last updated
Jul 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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