DementiaOrBiDNCT03775772
Oral Health, Bite Force and Dementia
A study testing Oral Health and Bite Force in people with Dementia and Oral Hygiene, run by University of Zurich at 1 site in Switzerland.
Trial summary
Study aims: The primary aim is to identify influencing variables on oral hygiene / oral health and bite force in patients with dementia. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Oral Hygiene, Chewing Problem
- What is being tested?
- Oral Health and Bite Force
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Dec 2018to 31 Dec 2020
- 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 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 59 years
- no acute processes being present
- no known cranio-mandibular dysorder (CMD) or finding of any CMD during study participation
- non or Maximum of one dental hygiene treatment in the last 12 months
Who cannot join
- younger than 60 years
- acute processes in the oral-facial Region
- known CDM case
- more than one dental hygiene treatment in the last 12 months
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Clinic of General, Special Care and Geriatric Dentistry
Zurich, 5621
Julia Kunze, Dr., +41 44 63 43 334, julia.kunze@zzm.uzh.ch
About this study
Official title: Oral Health, Bite Force and Dementia - A Randomized Controlled Clinical Trial
Study aims: The primary aim is to identify influencing variables on oral hygiene / oral health and bite force in patients with dementia.
- Conditions
- Dementia, Oral Hygiene, Chewing Problem
- Being tested
- Oral Health, Bite Force
- Keywords
- oral health, bite force, chewing efficiency, dementia, elderly, aged
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral HealthProcedure or surgery
- test group will receive an dental hygiene program for one year
- control group will remain with dental hygiene regime like done before study participation (maximum of two dental hygiene Treatments per year)
Bite ForceProcedure or surgery
- test group will receive physiotherapy with the aim of increasing muscle strength in chewing muscles for 3 months
- control group will remain without such training
| Study group | Role | What they receive |
|---|---|---|
| Oral Health - Test Group | Other | - study population is randomly assigned to control and test group Receives: Procedure: Oral Health |
| Bite Force/Chewing Efficacy-Test Group | Other | - study population is randomly assigned to control and test group Receives: Procedure: Bite Force |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Health (dental examination)
Decayed, Missing, Filled - Index (dmf/t)
Measured: 1 year
Chewing function I (examination with force gauge meter)
Bite Force (Bite Force Meter in Newton)
Measured: 1 year
Secondary outcomes (3)
Nutrition I (questionnaire/ assessment of nutritional state)
Mini Nutritional Assessment (MNA) (Malnutrition present? yes/no/at risk)
Measured: 1 year
Nutrition II (examination for weight and body-size)
Body Mass Index (BMI) (normal weight / under-weight / over-weight)
Measured: 1 year
Chewing function II (two-coloured chewing gum to test efficacy)
Chewing Efficacy (chew two-coloured chewing gum 20 times, visual and optoelectronic evaluation)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start13 Dec 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Kunze, Dr., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775772
- Sponsor's protocol ID
- 2017_OrBiD_RCT
- Acronym
- OrBiD
- Status last verified
- Dec 2018
- First submitted
- 23 Jun 2017
- Last updated
- 14 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jockusch J, Hahnel S, Nitschke I. Use of handgrip strength measurement as an alternative for assessing chewing function in people with dementia. BMC Geriatr. 2022 Sep 24;22(1):769. doi: 10.1186/s12877-022-03452-2.
PubMed 36153477Jockusch J, Hopfenmuller W, Nitschke I. Influence of cognitive impairment and dementia on oral health and the utilization of dental services : Findings of the Oral Health, Bite force and Dementia Study (OrBiD). BMC Oral Health. 2021 Aug 14;21(1):399. doi: 10.1186/s12903-021-01753-3.
PubMed 34391408
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health, Bite Force and Dementia - A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03775772
- Acronym / sponsor ID
- OrBiD / 2017_OrBiD_RCT
- Conditions
- Dementia, Oral Hygiene, Chewing Problem
- Keywords
- oral health, bite force, chewing efficiency, dementia, elderly, aged
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 Dec 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.
Study aims: The primary aim is to identify influencing variables on oral hygiene / oral health and bite force in patients with dementia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Health - Test Group | Other | Procedure: Oral Health- study population is randomly assigned to control and test group |
| Bite Force/Chewing Efficacy-Test Group | Other | Procedure: Bite Force- study population is randomly assigned to control and test group |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 59 years
- no acute processes being present
- no known cranio-mandibular dysorder (CMD) or finding of any CMD during study participation
- non or Maximum of one dental hygiene treatment in the last 12 months
Key exclusion criteria (4 listed)
- younger than 60 years
- acute processes in the oral-facial Region
- known CDM case
- more than one dental hygiene treatment in the last 12 months
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 |
|---|---|---|
| Oral Health* test group will receive an dental hygiene program for one year * control group will remain with dental hygiene regime like done before study participation (maximum of two dental hygiene Treatments per year) | Procedure or surgery | Oral Health - Test Group |
| Bite Force* test group will receive physiotherapy with the aim of increasing muscle strength in chewing muscles for 3 months * control group will remain without such training | Procedure or surgery | Bite Force/Chewing Efficacy-Test Group |
Primary outcome
Oral Health (dental examination)
Time frame: 1 year
Decayed, Missing, Filled - Index (dmf/t)
Chewing function I (examination with force gauge meter)
Time frame: 1 year
Bite Force (Bite Force Meter in Newton)
3 secondary outcomes
Nutrition I (questionnaire/ assessment of nutritional state)
Time frame: 1 year
Nutrition II (examination for weight and body-size)
Time frame: 1 year
Chewing function II (two-coloured chewing gum to test efficacy)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
- Derived from this study: PubMed 36153477Jockusch J, Hahnel S, Nitschke I. Use of handgrip strength measurement as an alternative for assessing chewing function in people with dementia. BMC Geriatr. 2022 Sep 24;22(1):769. doi: 10.1186/s12877-022-03452-2.
- Derived from this study: PubMed 34391408Jockusch J, Hopfenmuller W, Nitschke I. Influence of cognitive impairment and dementia on oral health and the utilization of dental services : Findings of the Oral Health, Bite force and Dementia Study (OrBiD). BMC Oral Health. 2021 Aug 14;21(1):399. doi: 10.1186/s12903-021-01753-3.
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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.
Julia Kunze, Dr. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Health and Bite Force in people with Dementia and Oral Hygiene, run by University of Zurich at 1 site in Switzerland.
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 4 inclusion and 4 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 Dec 2018. 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 Switzerland. 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?
Contact Julia Kunze, Dr. (+41 44 63 43 334, julia.kunze@zzm.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Health (dental examination) (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT03775772, which also lists 2 linked publications.
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 Dec 2018.