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

NCT ID: NCT01639183

Last Updated: 2013-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-07-31

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.

Conditions

Periodontal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Rotating-oscillating Power Toothbrush

Nursing home residents will be randomly assigned to receive power toothbrushing twice daily by their caregivers using a rotating-oscillating power toothbrush.

Group Type: EXPERIMENTAL

Rotating-oscillating Power Toothbrush

Intervention Type: DEVICE

A power toothbrush will be used twice daily for performing daily oral care on nursing home residents by their caregivers.

Standard Care

This arm comprises the control group where nursing home residents will receive standard daily oral care as usual.

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: OTHER

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

Interventions

Rotating-oscillating Power Toothbrush

A power toothbrush will be used twice daily for performing daily oral care on nursing home residents by their caregivers.

Intervention Type: DEVICE

Standard Care

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

Intervention Type: OTHER

Other Intervention Names

Oral-B Professional series 5000 (Proctor & Gamble Co.)

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Foundation for Dental Hygiene Research and Education

OTHER

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Salme E. Lavigne

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Salme E Lavigne, MS

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Deer Lodge Centre

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

H2012:227

Identifier Type: -

Identifier Source: org_study_id