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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
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

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

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
July 10, 2012
Last Updated
July 23, 2013
Sponsor
University of Manitoba
Collaborators
Canadian Foundation for Dental Hygiene Research and Education
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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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