Periodontal DiseaseNCT01639183
Power Toothbrush Use in Nursing Homes to Eliminate Mouth and Body Inflammation
A study testing Rotating-oscillating Power Toothbrush in people with Periodontal Disease, run by University of Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- Rotating-oscillating Power Toothbrush
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Residents of Nursing Home
- Presence of any natural teeth
- Non-aggressive behavior
- Presence of Periodontal inflammation
Who cannot join
- Smoking
- Comatose
- On a ventilator
- Aggressive behavior
- Presence of communicable disease
- On antibiotics
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Rotating-oscillating Power Toothbrush, Standard Care
- Keywords
- oral inflammation, systemic inflammation, compliance, power toothbrushing, nursing home residents
- Medical subject headings
- Periodontal Diseases, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotating-oscillating Power ToothbrushDevice
Also called Oral-B Professional series 5000 (Proctor & Gamble Co.)
A power toothbrush will be used twice daily for performing daily oral care on nursing home residents by their caregivers.
Standard CareOther
Standard daily oral hygiene care by caregivers of nursing home residents whatever that standard care may be.
| Study group | Role | What they receive |
|---|---|---|
| Rotating-oscillating Power Toothbrush | Experimental | Nursing home residents will be randomly assigned to receive power toothbrushing twice daily by their caregivers using a rotating-oscillating power toothbrush. Receives: Device: Rotating-oscillating Power Toothbrush |
| Standard Care | Active comparator | This arm comprises the control group where nursing home residents will receive standard daily oral care as usual. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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)
Measured: 6 weeks
Secondary outcomes (1)
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)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Foundation for Dental Hygiene Research and Education
- Responsible party
- Principal investigator, Salme E. Lavigne, University of Manitoba
- Investigators
- Salme E Lavigne, MS, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639183
- Sponsor's protocol ID
- H2012:227
- Status last verified
- Jul 2013
- First submitted
- 10 Jul 2012
- Last updated
- 24 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01639183
- Acronym / sponsor ID
- H2012:227
- Conditions
- Periodontal Disease
- Keywords
- oral inflammation, systemic inflammation, compliance, power toothbrushing, nursing home residents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canadian Foundation for Dental Hygiene Research and Education
- Study start
- Sep 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 12 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotating-oscillating Power Toothbrush | Experimental | Device: Rotating-oscillating Power ToothbrushNursing home residents will be randomly assigned to receive power toothbrushing twice daily by their caregivers using a rotating-oscillating power toothbrush. |
| Standard Care | Active comparator | Other: Standard CareThis arm comprises the control group where nursing home residents will receive standard daily oral care as usual. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Residents of Nursing Home
- Presence of any natural teeth
- Non-aggressive behavior
- Presence of Periodontal inflammation
Key exclusion criteria (6 listed)
- Smoking
- Comatose
- On a ventilator
- Aggressive behavior
- Presence of communicable disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotating-oscillating Power ToothbrushAlso: Oral-B Professional series 5000 (Proctor & Gamble Co.)A power toothbrush will be used twice daily for performing daily oral care on nursing home residents by their caregivers. | Device | Rotating-oscillating Power Toothbrush |
| Standard CareStandard daily oral hygiene care by caregivers of nursing home residents whatever that standard care may be. | Other | Standard Care |
Primary outcome
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.
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.
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)
1 secondary outcome
Oral Plaque on Teeth
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salme E Lavigne, MS principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotating-oscillating Power Toothbrush in people with Periodontal Disease, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Compliance (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2013.