Shared Oral Care - Improving Oral Care in Institutionalized Elderly in Aalborg Municipality
1 other identifier
interventional
258
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
Longer than P75 for not_applicable
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
January 10, 2018
CompletedFirst Posted
Study publicly available on registry
January 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedJuly 14, 2020
July 1, 2020
4.2 years
January 10, 2018
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 COMPARATORControl
NO INTERVENTIONInterventions
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.
Eligibility Criteria
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
Study Officials
- PRINCIPAL INVESTIGATOR
Karin Aagaard, PhD
Aalborg University
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