Clinical trial NCT06557226: Oral (Hypo-)Function, General Function and Nutritional Status in Elderly Hospitalized Patients
Official title: Oral (Hypo-)Function, General Function and Nutritional Status in Elderly Hospitalized Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Health
Oral Health Related Quality of Life
Nutrition Disorders in Old Age
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 61
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* • 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Malnutrition status as classified by the Global Leadership Initiative on Malnutrition (GLIM)
timeFrame: baseline
measure: Number of impaired oral functions
timeFrame: baseline
Secondary outcomes:
measure: Oral health related quality of life
timeFrame: baseline
Other outcomes:
Locations:
city: Genève
country: Switzerland
facility: University clinics of dental medicine
state: Geneva
city: Geneva
country: Switzerland
facility: Geneva University Hospital
Study officials:
affiliation: University Hospital, Geneva
name: Christophe Graf, Pr.
role: STUDY_DIRECTOR
References: