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Impaired HealthNCT02676453

Dental Hygienist Support Promotes Good Oral Health in Nursing Homes

A study testing Intervention in people with Impaired Health, run by Public Dental Health, Varmland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objective: The aim of this study was to evaluate the effects of dental hygienist support on oral health and attitudes to oral healthcare in nursing homes for older people. Background: Studies in long-term care facilities have indicated that oral health is often unsatisfactory. Read more about this study

Who is it for?
Any age
Conditions the study is for
Impaired Health
What is being tested?
Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
No sites listed yet
Study dates
Sep 2014to Apr 2015
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Residents at a nursing home
  • Natural teeth

Who cannot join

  • Edentulous

About this study

Objective: The aim of this study was to evaluate the effects of dental hygienist support on oral health and attitudes to oral healthcare in nursing homes for older people.

Background: Studies in long-term care facilities have indicated that oral health is often unsatisfactory. It is important that nursing staff are able to assist dependent care recipients. Dental hygienist support has been suggested as valuable help.

Material and methods: Two nursing homes were randomly selected for intervention and control. Interventions included weekly support from dental hygienists on oral hygiene procedures, prescriptions for individual oral hygiene procedures, and oral care organisational issues. The residents' oral health, measured by dental plaque levels, gingival bleeding and the Revised Oral Assessment Guide (ROAG), was evaluated before and after three months. Attitudes among the staff to oral healthcare were collected through a questionnaire.

Read the detailed description

Introduction Oral health in older people has been the subject of several studies from different perspectives in recent decades. These studies describe the difficulties in achieving a holistic view in healthcare when it comes to oral health for older people, and a lack of awareness among nursing staff that infections in the oral cavity may also affect other parts of the body. In a randomised study, it was shown that professional oral healthcare may improve oral conditions in elderly people. Studies have shown correlations between poor oral hygiene and pneumonia in elderly people. It has also been shown that both chewing ability and daily nutritional intake may be adversely affected in individuals with partial or full dentures compared to those with natural teeth or crown and bridge work.

To ensure good oral health and function, it is of great importance that nursing staff are able to support dependent older people in their daily oral care. Basic oral health knowledge among nursing staff and further training in oral hygiene procedures have been reported to be essential to good quality in oral care. In a study from Norway, it was shown that the residents' oral hygiene in nursing homes was significantly improved when an oral healthcare program was introduced. The program consisted of new procedures and tools for good oral hygiene, as well as practical training in oral care for nursing staff.

An earlier study by the authors of the present study captured the views of staff in various nursing homes for older people on important aspects for well-functioning daily oral care for residents. This study emphasised organisational structures involving oral hygiene procedures, staff approach regarding prioritising oral hygiene and keeping up skills in oral hygiene procedures, and staff views on residents' needs including matters such as how to act when a resident refuses help with oral care. Support by a dental hygienist in the nursing home was perceived as valuable help. Other authors have made similar findings in long-term care facilities, indicating that oral hygiene may be unsatisfactory due to organisational factors such as lack of a standard protocol for oral hygiene procedures, lack of time and conflicting priorities, lack of knowledge among care providers and cooperation difficulties among some residents.

The aim of the present study was to evaluate the effects of dental hygienist support on oral health and attitudes to oral health care in nursing homes for older people.

Material and Methods The study had a quantitative design with two comparable study groups with older people in two nursing homes. The two most centrally situated public nursing homes in the largest municipality in the county of Värmland in Sweden were randomly selected as intervention and control group. The Regional Ethical Review Board in Uppsala approved the study.

Study material The two nursing homes were comparable regarding size, resident profile, and staffing. The residents included older people with dementia, physical disabilities or long-term illnesses. One director of nursing, one registered nurse and 21 nursing assistants worked at the intervention nursing home. One director of nursing, one registered nurse and 28 nursing assistants worked at the control nursing home. All but one of the staff members were women. There were 33 residents in each of the two nursing homes. Only dentate residents were included.

Procedures The Director of Social Services in the municipality was given verbal and written information and approved the study. The directors of nursing at the intervention and control nursing homes were separately informed, both verbally and in writing, about the procedures for their respective part of the study. They were not informed which additional nursing home was participating in the study. The directors of nursing at both nursing homes supplied the residents or their relatives with written information about the study and asked for written consent. Only those who consented to participate in the study were included. Edentulous residents were excluded from the study. The nursing assistants agreed to participate in the study.

Intervention

In the intervention nursing home, the study dental hygienists offered regular support over the course of three months, comprising the following:

  • Participation in staff meetings with the director of nursing and nursing assistants at the beginning of the study, after six weeks and at the end of the study period. At those meetings, oral care routines were discussed and a concept of prescriptions for individual oral hygiene procedures was introduced (see below).
  • Visits to the nursing home once a week. For two hours in the morning, the dental hygienists accompanied and supported the nursing staff in their oral hygiene care and gave advice on daily oral hygiene procedures for each resident participating in the study. Specific difficulties concerning residents with cooperation problems were addressed. Each weekly visit ended with a 30 min meeting in which the nursing staff had the opportunity to discuss oral hygiene procedures and oral health issues with the dental hygienists.
  • Individual written oral hygiene prescriptions for special oral hygiene devices, procedures or products. These were issued by the dental hygienists to residents with an identified need for extra oral care support, i.e. with scores >1 in the Revised Oral Assessment Guide (ROAG) evaluation.

Control

At study start, the director of nursing for the control nursing home was informed about the importance of good oral hygiene and was invited to contact the two study dental hygienists if support was needed with any particular oral health issue or dental hygiene procedure.

Clinical evaluation of oral health Clinical evaluations of the residents' oral health status were blinded. An independent dentist and dental hygienist, otherwise not committed to the planning of the study and not informed about which was the intervention nursing home, conducted a dental examination of the residents who had consented to take part in the study in both nursing homes. This was done at the beginning of the study and three months later at the end of the study. The staff were not informed about the scheduled time for the clinical evaluations of the residents' oral health.

Conditions
Impaired Health
Being tested
Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02676453
Study groupRoleWhat they receive
InterventionExperimentalDental hygienist support
Receives: Other: Intervention
controlNo interventionCare as usal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in dental plaque levels after three months

    Four surfaces (proximal, buccal and lingual surfaces) on each tooth is measured and regarding dental plaque in four levels.

    Measured: 3 months

  2. Changes in gingival bleeding levels after three months

    Four surfaces (proximal, buccal and lingual surfaces) on each tooth is measured and regarding gingival bleeding in four levels.

    Measured: 3 months

Secondary outcomes (1)
  1. Changes in Revised Oral Assessment Guide, ROAG, after 3 months

    ROAG includes assessment of voice, lips, oral mucosa, tongue, gums, teeth, dentures, saliva and swallowing ability. Each item was rated according to a ROAG score of 1 (normal), 2 (minor problems) and 3 (severe problems). Definitions are given for each item in ROAG. For example, the item "teeth" includes the following definitions: 1 (normal) clean teeth, no visible plaque or food debris, 2 (minor problems) plaque or food debris in localised areas, 3 (severe problems) generalised plaque, food debris or defective teeth. The item "gums" includes the following definitions: 1 (normal) pink and firm, 2 (minor problems) edematous with or without redness, 3 (severe problems) spontaneous bleeding. The item "lips" includes: 1 (normal) smooth, pink, moist, 2 (minor problems) dry or cracked, angular cheilitis, 3 (severe problems) ulcerated or bleeding.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2016 (estimated)
  2. Study startSep 2014
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02676453
Sponsor's protocol ID
VarmlandBL
Status last verified
Feb 2016
First submitted
1 Feb 2016
Last updated
8 Feb 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Impaired Health, run by Public Dental Health, Varmland.

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 2 inclusion and 1 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 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Changes in dental plaque levels after three months (time frame: 3 months). The study lists 2 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 8 Feb 2016.

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