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

July 23, 2013 updated by: Salme E. Lavigne, University of Manitoba

The Effects of Daily Power Toothbrushing on Caregiver Compliance and on Oral and Systemic Inflammation in a Nursing Home Population: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3J 0L3
        • Deer Lodge Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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 Names:
  • Oral-B Professional series 5000 (Proctor & Gamble Co.)
Active Comparator: Standard Care
This arm comprises the control group where nursing home residents will receive standard daily oral care as usual.
Other: Standard Care
Standard daily oral hygiene care by caregivers of nursing home residents whatever that standard care may be.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver Compliance
Time Frame: 6 weeks
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
Systemic Inflammation
Time Frame: 6 weeks
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
Oral Inflammation
Time Frame: 6 weeks

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Plaque on Teeth
Time Frame: 6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

Canadian Foundation for Dental Hygiene Research and Education

Investigators

  • Principal Investigator: Salme E Lavigne, MS, University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

July 10, 2012

First Submitted That Met QC Criteria

July 11, 2012

First Posted (Estimate)

July 12, 2012

Study Record Updates

Last Update Posted (Estimate)

July 24, 2013

Last Update Submitted That Met QC Criteria

July 23, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H2012:227

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Periodontal Disease

Clinical Trials on Rotating-oscillating Power Toothbrush

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe