Power Toothbrush Use in Nursing Homes to Eliminate Mouth and Body Inflammation
The Effects of Daily Power Toothbrushing on Caregiver Compliance and on Oral and Systemic Inflammation in a Nursing Home Population: A Randomized Controlled Trial
1 other identifier
interventional
58
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2012
CompletedFirst Posted
Study publicly available on registry
July 12, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJuly 24, 2013
July 1, 2013
10 months
July 10, 2012
July 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Caregiver Compliance
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.
6 weeks
Systemic Inflammation
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.
6 weeks
Oral Inflammation
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)
6 weeks
Secondary Outcomes (1)
Oral Plaque on Teeth
6 weeks
Study Arms (2)
Rotating-oscillating Power Toothbrush
EXPERIMENTALNursing home residents will be randomly assigned to receive power toothbrushing twice daily by their caregivers using a rotating-oscillating power toothbrush.
Standard Care
ACTIVE COMPARATORThis arm comprises the control group where nursing home residents will receive standard daily oral care as usual.
Interventions
A power toothbrush will be used twice daily for performing daily oral care on nursing home residents by their caregivers.
Standard daily oral hygiene care by caregivers of nursing home residents whatever that standard care may be.
Eligibility Criteria
You may qualify if:
- Residents of Nursing Home
- Presence of any natural teeth
- Non-aggressive behavior
- Presence of Periodontal inflammation
You may not qualify if:
- Smoking
- Comatose
- On a ventilator
- Aggressive behavior
- Presence of communicable disease
- On antibiotics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Deer Lodge Centre
Winnipeg, Manitoba, R3J 0L3, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Salme E Lavigne, MS
University of Manitoba
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 10, 2012
First Posted
July 12, 2012
Study Start
September 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
July 24, 2013
Record last verified: 2013-07