Oral HealthOhypNCT06557226
Oral (Hypo-)Function, General Function and Nutritional Status in Elderly Hospitalized Patients
An observational study of Oral Health and Oral Health Related Quality of Life, run by University of Geneva, Switzerland at 2 sites in Switzerland.
Trial summary
The goal of this observational study is to learn about the effects of a reduced oral function on the nutritional status of non-acute hospitalized elders and on their oral health quality of life. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Health, Oral Health Related Quality of Life, Nutrition Disorders in Old Age
- What is being tested?
- oral and nutritional examination
- Type of treatment
- Pill or oral medicine
- How many people
- 61 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 12 Sep 2020to 10 Sep 2023
- Phase
- Observational
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: This study will enroll 60 patients aged 70 years or more and admitted to the Geneva University Hospitals (HUG) at Loëx Hospital. Patients will be approached consecutively.
Who may be able to join
- • Aged 70 years or over
- Hospitalized in Geneva University Hospitals, in rehabilitation or in long term care (Loëx)
- Able to follow simple instructions and perform the tests
- Understand French and complete or answer the questionnaire
- Give written informed consent
- Consent can be obtained from their next of kin or legal representative if necessary
- Have been admitted into the hospital no longer 15 days before inclusion
Who cannot join
- Patients with tube/intravenous feeding
- Poorly-controlled diabetes (Liu et al., 2015)
- Patients with gastro-intestinal diseases or symptoms (nausea, vomiting, diarrhea, constipation) affecting oral intake
- If the patient is taking an antimicrobial treatment at this time.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University clinics of dental medicine
Geneva, Canton of Geneva, 1211
Geneva University Hospital
Geneva, Canton of Geneva, 1233
About this study
The goal of this observational study is to learn about the effects of a reduced oral function on the nutritional status of non-acute hospitalized elders and on their oral health quality of life.
Read the detailed description
Malnutrition is highly prevalent among the elderly, many authors reported on the relationship between oral health and nutrition. However the the relationship between the dental state and the nutritional status was always limited to anatomical criteria such as number of teeth and the presence of prosthetic reconstructions.
The oral function is classified into 4 stages healthy state, oral frailty, oral hypofunction and oral dysfunction. The classification into the different stages result from an examination of 7 parameters: the oral hygiene, the oral dryness, the occlusal force, the tongue-lip motor function, the tongue pressure, the chewing function and the swallowing function.
This study aims to correlate the oral function with the nutritional status of non-acute hospitalized elders. And to further investigate the correlation between the different parameters defining the oral function and the oral health related quality of life (OHRQoL) as measured by theGeneral Oral Health Assessment Index.
A total 60 participants will be recruited in the University Hospital of Geneva, Loëx rehabilitation center. The investigators will see the patient for 2 visits after informed consent. The first visit will be 45 minutes long and will include a dental examination and an examination of the oral hygiene, the oral dryness, the tongue lip motor function, the tongue pressure, the occlusal force and the swallowing function. Diagnosis for nutrition according to the Glim criteria will be done. Furthermore, the participants will be asked to fill an oral health quality of life questionnaire comprising 12 questions.
Oral hypo function will be defined as a state when 3 or more signs were present from the 7 parameters examined.
Linear multiple regression analysis is used to examine the relationship between the nutritional status and oral function. Spearman's rank correlation coefficient will be used to correlate the oral function score and oral health related quality of life.
- Being tested
- oral and nutritional examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral and nutritional examinationOther
Participants will receive a comprehensive oral examination, nutritional examination and will fill an oral health related quality of life questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| patient with oral hypofunction with 3 impaired oral functional parameters | patient's will receive an oral examination comprising the evaluation of 7 parameters: the oral hygiene, the oral dryness, the occlusal force, the tongue-lip motor function, the tongue pressure, the chewing function and the swallowing function. Oral hypofunction is defined as a state when 3 or more signs were present. Receives: Other: oral and nutritional examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malnutrition status as classified by the Global Leadership Initiative on Malnutrition (GLIM)
The GLIM considers both (a) phenotypic (>5% weight loss within the previous 6 months or >10% weight loss in more than 6 months, BMI < 22 kg/m2 if age >70 years, FFMI <17 kg/m2 in men and <15 kg/m2 in women) and (b) aetiologic criteria (reduced food intake and level of inflammation with CRP >10 mg/L). Participants were classified as malnourished when at least 1 phenotypic criterion and 1 aetiologic criterion were met. The severity of the malnutrition is based on the phenotypic criteria in a stage 1 "moderate malnutrition" and stage 2 "severe malnutrition." The participants were classified on a score scale from 0- 2 with o being normal, 1 for the moderate malnutrition and 2 for the severe malnutrition.
Measured: baseline
Number of impaired oral functions
The Japanese society of gerodontology in 2016 published a position paper aiming to standardize the examination of oral disorders related to age and to suggest management strategies. They created a conceptual diagram divided into 4 stages: healthy state, oral frailty, oral hypofunction and oral dysfunction. The classification into the different stages result from an examination of 7 parameters: the oral hygiene, the oral dryness, the occlusal force, the tongue-lip motor function, the tongue pressure, the chewing function and the swallowing function. Oral hypofunction is defined as a state when 3 or more signs were present.
Measured: baseline
Secondary outcomes (1)
Oral health related quality of life
General oral health assessment index (GOHAI) is a self-reported measure designed to assess the impact on daily life of oral health problems of older individuals. The 12 item GOHAI evaluates three dimensions of oral health related quality of life study (OHRQOL).
The GOHAI score is determined by summing the final score of each of the 12 items ranges from 0 to 60 with higher scores indicating better oral health.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start12 Sep 2020
- Primary completion10 Sep 2023
- Study completion10 Sep 2023
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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frauke Müller, University of Geneva, Switzerland
- Investigators
- Christophe Graf, Pr., Study director, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557226
- Sponsor's protocol ID
- 2019-01338
- Other IDs
- 2019
- Acronym
- Ohyp
- Status last verified
- Mar 2025
- First submitted
- 1 Jul 2024
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral (Hypo-)Function, General Function and Nutritional Status in Elderly Hospitalized Patients
- ClinicalTrials.gov ID
- NCT06557226
- Acronym / sponsor ID
- Ohyp / 2019-01338
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Study start
- 12 Sep 2020 (actual)
- Primary completion
- 10 Sep 2023 (actual)
- Study completion
- 10 Sep 2023 (actual)
- First posted
- 16 Aug 2024 (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.
The goal of this observational study is to learn about the effects of a reduced oral function on the nutritional status of non-acute hospitalized elders and on their oral health quality of life.
Detailed description
Malnutrition is highly prevalent among the elderly, many authors reported on the relationship between oral health and nutrition. However the the relationship between the dental state and the nutritional status was always limited to anatomical criteria such as number of teeth and the presence of prosthetic reconstructions.
The oral function is classified into 4 stages healthy state, oral frailty, oral hypofunction and oral dysfunction. The classification into the different stages result from an examination of 7 parameters: the oral hygiene, the oral dryness, the occlusal force, the tongue-lip motor function, the tongue pressure, the chewing function and the swallowing function.
This study aims to correlate the oral function with the nutritional status of non-acute hospitalized elders. And to further investigate the correlation between the different parameters defining the oral function and the oral health related quality of life (OHRQoL) as measured by theGeneral Oral Health Assessment Index.
A total 60 participants will be recruited in the University Hospital of Geneva, Loëx rehabilitation center. The investigators will see the patient for 2 visits after informed consent. The first visit will be 45 minutes long and will include a dental examination and an examination of the oral hygiene, the oral dryness, the tongue lip motor function, the tongue pressure, the occlusal force and the swallowing function. Diagnosis for nutrition according to the Glim criteria will be done. Furthermore, the participants will be asked to fill an oral health quality of life questionnaire comprising 12 questions.
Oral hypo function will be defined as a state when 3 or more signs were present from the 7 parameters examined.
Linear multiple regression analysis is used to examine the relationship between the nutritional status and oral function. Spearman's rank correlation coefficient will be used to correlate the oral function score and oral health related quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with oral hypofunction with 3 impaired oral functional parameters | – | Other: oral and nutritional examinationpatient's will receive an oral examination comprising the evaluation of 7 parameters: the oral hygiene, the oral dryness, the occlusal force, the tongue-lip motor function, the tongue pressure, the chewing function and the swallowing function. Oral hypofunction is defined as a state when 3 or more signs were present. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- This study will enroll 60 patients aged 70 years or more and admitted to the Geneva University Hospitals (HUG) at Loëx Hospital. Patients will be approached consecutively.
Key inclusion criteria (7 listed)
- • Aged 70 years or over
Key exclusion criteria (4 listed)
- Patients with tube/intravenous feeding
- Poorly-controlled diabetes (Liu et al., 2015)
- Patients with gastro-intestinal diseases or symptoms (nausea, vomiting, diarrhea, constipation) affecting oral intake
- If the patient is taking an antimicrobial treatment at this time.
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 and nutritional examinationParticipants will receive a comprehensive oral examination, nutritional examination and will fill an oral health related quality of life questionnaire. | Other | patient with oral hypofunction with 3 impaired oral functional parameters |
Primary outcome
Malnutrition status as classified by the Global Leadership Initiative on Malnutrition (GLIM)
Time frame: baseline
The GLIM considers both (a) phenotypic (>5% weight loss within the previous 6 months or >10% weight loss in more than 6 months, BMI < 22 kg/m2 if age >70 years, FFMI <17 kg/m2 in men and <15 kg/m2 in women) and (b) aetiologic criteria (reduced food intake and level of inflammation with CRP >10 mg/L). Participants were classified as malnourished when at least 1 phenotypic criterion and 1 aetiologic criterion were met. The severity of the malnutrition is based on the phenotypic criteria in a stage 1 "moderate malnutrition" and stage 2 "severe malnutrition." The participants were classified on a score scale from 0- 2 with o being normal, 1 for the moderate malnutrition and 2 for the severe malnutrition.
Number of impaired oral functions
Time frame: baseline
The Japanese society of gerodontology in 2016 published a position paper aiming to standardize the examination of oral disorders related to age and to suggest management strategies. They created a conceptual diagram divided into 4 stages: healthy state, oral frailty, oral hypofunction and oral dysfunction. The classification into the different stages result from an examination of 7 parameters: the oral hygiene, the oral dryness, the occlusal force, the tongue-lip motor function, the tongue pressure, the chewing function and the swallowing function. Oral hypofunction is defined as a state when 3 or more signs were present.
1 secondary outcome
Oral health related quality of life
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Christophe Graf, Pr. study director
University Hospital, Geneva
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Health and Oral Health Related Quality of Life, run by University of Geneva, Switzerland at 2 sites 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 7 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: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Malnutrition status as classified by the Global Leadership Initiative on Malnutrition (GLIM) (time frame: baseline). 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 30 Mar 2025.