Periodontal Disease Clinical Trial
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
Verified date | July 2013 |
Source | University of Manitoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Canada | Deer Lodge Centre | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba | Canadian Foundation for Dental Hygiene Research and Education |
Canada,
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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