CClinicalTrials.gg
Status unknownNCT03407339Updated Jul 14, 2020

Shared Oral Care - Improving Oral Care in Institutionalized Elderly in Aalborg Municipality

An interventional study of Shared Oral Care intervention in Oral Health and Quality of Life, sponsored by Aalborg University. Status unknown at 1 site in Denmark. Open to participants aged 65 Years to 105 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-14.

Sponsored by Aalborg University · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
258
Allocation
Randomized
Ages
65 Years to 105 Years
Sex
All
01

Study summary

Background:

Nationally and internationally, more people over the age of 65 and especially an increase of people over the age of 80 enter nursing homes with natural dentition and complex prostheses and bridges than previous generations. Furthermore, there is an increased incidence of dental diseases in the elderly. This is leading to increased and different oral care needs. There is a large discrepancy between the elderly who need help with oral hygiene and the elderly who actually receive help. In order to improve the oral hygiene competencies of healthcare professionals at nursing homes, it is necessary to increase their education and improve organizational strategies.

Hypothesis:

The Intervention Shared Oral Care improves the elderlys bleeding and plaque index after 6 months.

Study type:

An intervention study.

A cluster randomization of 14 nursing homes in Aalborg municipality is carried out.

Outcome Measures:

Change in mucosal-plaque score (MPS) index

Change in Oral Related Quality of life

Outcome Measure Time Frame:

Change in mucosal-plaque score index measured at 0, 3 and 6 months.

Change in Oral Related Quality of life measured at 0 and 6 months.

02

Conditions studied

  • Oral Health
  • Quality of Life
03

Who can participate

Ages eligible
65 Years to 105 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Elderly living in nursing homes in Aalborg Municipality Having one or more natural dentition

Exclusion criteria

Exclusion Criteria:

  • no natural dentition
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
258 participants (actual)

Study arms

  • Active comparator
    Shared Oral Care Intervention

    Other: Shared Oral Care intervention

  • No intervention
    Control

Interventions

  • OtherShared Oral Care intervention

    One hour of teaching in oral hygiene and oral diseases to health care professionals at the intervention nursing homes. The dentists will make an assessment of the elderly's oral hygiene at baseline, after three and six months using a mucosal and plaque score. During the six months, a dentist will be doing ward rounds at each nursing home in a specific time interval. In dialog with the resident and the healthcare professional, the dentist will present individual advice on how to perform oral care based on the resident's oral care routines, oral hygiene status, and the resident's physical and cognitive function level.

05

What researchers measure

Primary outcomes

  1. Change from baseline at 3 and 6 months in MPS index

    Mucosal Plaque Score Mucosal Score, MS (score 1-4), and Plaque Score, PS (score 1-4). The sum of MS and PS is labeled MI'S (score 2-8). An MPS status is judged as good or acceptable when MI'S = 2-4, as unacceptable when MPS = 5-6, and as poor when MI'S = 7-8.

    Time frame: baseline, 3 and 6 months

  2. Change from baseline at 6 months in modified Oral Health Impact Profile (OHIP14)

    modified Oral Health Impact Profile (OHIP14) The modified Oral Health Impact Profile: 1. Have you had painful aching in your mouth? 2. Do you have trouble biting or chewing any kinds of food, such as firm meat or apples? 3. Do you limit the kinds or amounts of food you eat because of problems with your dentures? 4. How often are your teeth or gums sensitive to hot, cold, or sweets? Responses are made in a five point scale: Very often = 4 Often = 3 Sometimes = 2 Seldom = 1 Never = 0 Do to cognitively impaired elderly the response "I don't know" is added to each question coded 9.

    Time frame: baseline and 6 months

06

Study locations

1 site
  • Aalborg University
    Aalborg, Nordjylland 9220, Denmark
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03407339
Lead sponsor
Aalborg University
Responsible party
Karin Aagaard (Assistant Professor, Aalborg University) — Principal investigator
First posted
Jan 23, 2018
Start date
Feb 1, 2017
Primary completion
Mar 31, 2021 (estimated)
Completion
Mar 31, 2021 (estimated)
Last update
Jul 14, 2020

Study contacts

Karin Aagaard, PhD
principal investigator · Aalborg University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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