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Clinical Trials/NCT06557226
NCT06557226
Completed
Not Applicable

Oral (Hypo-)function, General Function and Nutritional Status in Elderly Hospitalized Patients

University of Geneva, Switzerland2 sites in 1 country61 target enrollmentSeptember 12, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oral Health
Sponsor
University of Geneva, Switzerland
Enrollment
61
Locations
2
Primary Endpoint
Malnutrition status as classified by the Global Leadership Initiative on Malnutrition (GLIM)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 12, 2020
End Date
September 10, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Geneva, Switzerland
Responsible Party
Principal Investigator
Principal Investigator

Frauke Müller

Professor

University of Geneva, Switzerland

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Oral health related quality of life(baseline)

Study Sites (2)

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