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

NCT06557226 | Completed

• 1 other identifier: 2019-01338
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 2

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.

Conditions

Oral Health; Oral Health Related Quality of Life; Nutrition Disorders in Old Age

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  baseline

Secondary Outcomes (1)

• Oral health related quality of life

  baseline

Study Arms (1)

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.

Other: oral and nutritional examination

Interventions

oral and nutritional examination OTHER

Participants will receive a comprehensive oral examination, nutritional examination and will fill an oral health related quality of life questionnaire.

patient with oral hypofunction with 3 impaired oral functional parameters

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Geneva, Switzerland: lead

Study Sites (2)

University clinics of dental medicine

Geneva, Canton of Geneva, 1211, Switzerland

Location

Geneva University Hospital

Geneva, Canton of Geneva, 1233, Switzerland

Location

Study Officials

• Christophe Graf, Pr.

  University Hospital, Geneva

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: August 16, 2024
• Study Start: September 12, 2020
• Primary Completion: September 10, 2023
• Study Completion: September 10, 2023
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

CH (2)