NCT03407339

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
258

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

4.2 years

First QC Date

January 10, 2018

Last Update Submit

July 10, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    baseline, 3 and 6 months

  • 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.

    baseline and 6 months

Study Arms (2)

Shared Oral Care Intervention

ACTIVE COMPARATOR
Other: Shared Oral Care intervention

Control

NO INTERVENTION

Interventions

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.

Shared Oral Care Intervention

Eligibility Criteria

Age65 Years - 105 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • no natural dentition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University

Aalborg, North Denmark, 9220, Denmark

Location

Study Officials

  • Karin Aagaard, PhD

    Aalborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 23, 2018

Study Start

February 1, 2017

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations