Power Toothbrush Use in Nursing Homes to Eliminate Mouth and Body Inflammation

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01639183
• Other study ID #: H2012:227
• 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

Related Conditions & MeSH terms

• Gingival Diseases
• Inflammation
• Periodontal Disease
• Periodontal Diseases

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