Oral HealthNCT03407339
Shared Oral Care - Improving Oral Care in Institutionalized Elderly in Aalborg Municipality
A study testing Shared Oral Care intervention in people with Oral Health and Quality of Life, run by Aalborg University at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health, Quality of Life
- What is being tested?
- Shared Oral Care intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2017to 31 Mar 2021
- 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 65 to 105 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Elderly living in nursing homes in Aalborg Municipality Having one or more natural dentition
Who cannot join
- no natural dentition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shared Oral Care - Improving Oral Care in Institutionalized Elderly in Aalborg
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.
Read more
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.
- Conditions
- Oral Health, Quality of Life
- Being tested
- Shared Oral Care intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Oral Care interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Shared Oral Care Intervention | Active comparator | Not described Receives: Other: Shared Oral Care intervention |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
- 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.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Feb 2017
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karin Aagaard, Aalborg University
- Investigators
- Karin Aagaard, PhD, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407339
- Sponsor's protocol ID
- 2016-899/10-0250
- Status last verified
- Jul 2020
- First submitted
- 10 Jan 2018
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Oral Care - Improving Oral Care in Institutionalized Elderly in Aalborg
- ClinicalTrials.gov ID
- NCT03407339
- Acronym / sponsor ID
- 2016-899/10-0250
- Conditions
- Oral Health, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared Oral Care Intervention | Active comparator | Other: Shared Oral Care intervention |
| Control | No intervention | – |
Who may qualify
- Ages
- 65 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Elderly living in nursing homes in Aalborg Municipality Having one or more natural dentition
Key exclusion criteria (1 listed)
- no natural dentition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared Oral Care interventionOne 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. | Other | Shared Oral Care Intervention |
Primary outcome
Change from baseline at 3 and 6 months in MPS index
Time frame: 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)
Time frame: baseline and 6 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Aagaard, PhD principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared Oral Care intervention in people with Oral Health and Quality of Life, run by Aalborg University at 1 site in Denmark.
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 1 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: status not confirmed, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Change from baseline at 3 and 6 months in MPS index (time frame: baseline, 3 and 6 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 14 Jul 2020.