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

Sponsor

Aalborg University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03407339

Collaborator

(none)

258

Enrollment

Location

Arms

49.9

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Health Quality of Life	Other: Shared Oral Care intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

258 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Feb 1, 2017

Anticipated Primary Completion Date :

Mar 31, 2021

Anticipated Study Completion Date :

Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Shared Oral Care Intervention	Other: Shared 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.
No Intervention: Control

Arm

Intervention/Treatment

Active Comparator: Shared Oral Care Intervention

Other: Shared 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.

No Intervention: Control

Outcome Measures

Primary Outcome Measures

Change from baseline at 3 and 6 months in MPS index [baseline, 3 and 6 months]
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.
Change from baseline at 6 months in modified Oral Health Impact Profile (OHIP14) [baseline and 6 months]
modified Oral Health Impact Profile (OHIP14) The modified Oral Health Impact Profile: Have you had painful aching in your mouth? Do you have trouble biting or chewing any kinds of food, such as firm meat or apples? Do you limit the kinds or amounts of food you eat because of problems with your dentures? 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 105 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

no natural dentition

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aalborg University	Aalborg	Nordjylland	Denmark	9220

Sponsors and Collaborators

Aalborg University

Investigators

Principal Investigator: Karin Aagaard, PhD, Aalborg University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Karin Aagaard, Assistant Professor, Aalborg University

ClinicalTrials.gov Identifier:

NCT03407339

Other Study ID Numbers:

2016-899/10-0250

First Posted:

Jan 23, 2018

Last Update Posted:

Jul 14, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 14, 2020