Power Toothbrush Use in Nursing Homes to Eliminate Mouth and Body Inflammation
Primary Purpose
Periodontal Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Rotating-oscillating Power Toothbrush
Standard Care
Sponsored by
About this trial
This is an interventional prevention trial for Periodontal Disease focused on measuring oral inflammation, systemic inflammation, compliance, power toothbrushing, nursing home residents
Eligibility 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
Sites / Locations
- Deer Lodge Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rotating-oscillating Power Toothbrush
Standard Care
Arm Description
Nursing home residents will be randomly assigned to receive power toothbrushing twice daily by their caregivers using a rotating-oscillating power toothbrush.
This arm comprises the control group where nursing home residents will receive standard daily oral care as usual.
Outcomes
Primary Outcome Measures
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.
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.
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)
Secondary Outcome Measures
Oral Plaque on Teeth
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)
Full Information
NCT ID
NCT01639183
First Posted
July 10, 2012
Last Updated
July 23, 2013
Sponsor
University of Manitoba
Collaborators
Canadian Foundation for Dental Hygiene Research and Education
1. Study Identification
Unique Protocol Identification Number
NCT01639183
Brief Title
Power Toothbrush Use in Nursing Homes to Eliminate Mouth and Body Inflammation
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 Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
Canadian Foundation for Dental Hygiene Research and Education
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease
Keywords
oral inflammation, systemic inflammation, compliance, power toothbrushing, nursing home residents
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rotating-oscillating Power Toothbrush
Arm Type
Experimental
Arm Description
Nursing home residents will be randomly assigned to receive power toothbrushing twice daily by their caregivers using a rotating-oscillating power toothbrush.
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
This arm comprises the control group where nursing home residents will receive standard daily oral care as usual.
Intervention Type
Device
Intervention Name(s)
Rotating-oscillating Power Toothbrush
Other Intervention Name(s)
Oral-B Professional series 5000 (Proctor & Gamble Co.)
Intervention Description
A power toothbrush will be used twice daily for performing daily oral care on nursing home residents by their caregivers.
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Standard daily oral hygiene care by caregivers of nursing home residents whatever that standard care may be.
Primary Outcome Measure Information:
Title
Caregiver Compliance
Description
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.
Time Frame
6 weeks
Title
Systemic Inflammation
Description
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.
Time Frame
6 weeks
Title
Oral Inflammation
Description
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)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Oral Plaque on Teeth
Description
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)
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salme E Lavigne, MS
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deer Lodge Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3J 0L3
Country
Canada
12. IPD Sharing Statement
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Power Toothbrush Use in Nursing Homes to Eliminate Mouth and Body Inflammation
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