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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01639183
Other study ID # H2012:227
Secondary ID
Status Completed
Phase N/A
First received July 10, 2012
Last updated July 23, 2013
Start date September 2012
Est. completion date July 2013

Study information

Verified date July 2013
Source University of Manitoba
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Intervention

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

Locations

Country Name City State
Canada Deer Lodge Centre Winnipeg Manitoba

Sponsors (2)

Lead Sponsor Collaborator
University of Manitoba Canadian Foundation for Dental Hygiene Research and Education

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 Yes
Primary 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 No
Secondary 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) 6 weeks No
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