Clinical trial NCT04656327: Oral Health Status in Care-dependent Community Dwelling Elders
Official title: Oral Health Status in Care-dependent Community Dwelling Elders: a Cross-sectional Study in Zurich
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral-health
Nutritional Status
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly population living in the canton of Zurich, who are care-dependent and community- dwelling receiving out-patient care.

Brief summary: The primary aim of this cross-sectional survey in Zurich is to assess the oral health status (OHS), Oral Health Related Quality of Life (OHRQoL), and the nutritional status (NS) of community-dwelling elders dependent for care. The secondary objective of this study evaluates whether the OHS, OHRQoL and NS are influenced by cognitive status, level of dependency, socio-economic status and level of education. The tertiary objective is to assess whether the quality of nutritional uptake (refrigerator content) by the community-dwelling elders dependent for care is influenced by OHS/function, level of dependency, cognitive impairment, socio-economic status or level of education and the proximity and/or access to food sources (supermarkets).

Detailed description: Aim: The aim of this cross-sectional study is to assess the oral health status, Oral Health Related Quality of Life, and the nutritional status of community-dwelling elderly adults requiring care for their activities of daily living.

Methods:

Community dwelling elders residing in their homes but receiving out-patient care will be recruited in this study. Participants will receive a detailed oral examination at their residences. Their oral health status and oral function will be evaluated according to the following indices: DMF(T), plaque index (Plx), gingival index (GIx), community periodontal index for treatment needs (CPITN), xerostomia inventory (XI), brushing habits, denture calculus index (DCI), Denture Assessment (Marxkors Criteria), chewing efficiency (CE) and maximum bite force (MBF). The quality of oral care will be assessed by the use and condition of the prevalent oral hygiene tools according to the Toothbrush wear rate (TBWR). Furthermore, the Quality of Life (QoL) and Oral Health Related Quality of Life (OHRQoL) will be measured with the Oral health impact profile 14 items (OHIP-14) and EuroQol-5D (EQ-5D). Finally, the nutritional status of these care-dependent elders will be recorded with the mini nutritional assessment (MNA) as well as the recording their refrigerator content along with a 24-hour diet chart.

Discussion:

The population is ageing worldwide and teeth are being retained to an advanced age. Oral health however declines, in elders dependent for care, due to age associated complications including, multi morbidity, poly-pharmacy, cognitive and physical impairments. As a consequence, edentulous state prevails at a later age. Prevention and oral hygiene maintenance become difficult in these elders and even more complex in those who are rehabilitated with prosthetic reconstructions. Oral hygiene and care is very important in these individuals to prevent and intervene the disease process. Tooth loss combined with cognitive decline, frailty and other age-associated complications may lead to malnutrition. This study hopes to provide a reliable evaluation of the current oral health and nutritional status of elderly people living in the community and are dependent for care in an industrialised country. These data are considered cardinal and imperative for both government policies in terms of preventive programs, health educations, as well as for the organisation providing these care services.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent
2. Living in their residence in the canton of Zurich but dependent for care for their Activities of Daily Living (ADLs)

Exclusion Criteria:

1. Not willing or able to sign informed consent or not given by the caregiver/guardian.
2. Age \< 65 years
3. Non-responsive / not cooperative for examination

Primary outcomes:
measure: Plaque Index
timeFrame: Day 1
measure: Gingival index
timeFrame: Day 1
measure: DMF(T)
timeFrame: Day 1
measure: CPITN index
timeFrame: Day 1
measure: Dentition Status
timeFrame: Day 1
measure: Denture Calculus index (DCI)
timeFrame: Day 1
measure: Maximum bite force (MBF)
timeFrame: Day 1
measure: Chewing function (CE)
timeFrame: Day 1
measure: Oral health impact profile 14-items (OHIP-14)
timeFrame: Day 1
measure: European Quality of Life - 5 Dimensions (EQ-5D)
timeFrame: Day 1
measure: Xerostomia Inventory with 11-items (XI-11)
timeFrame: Day 1
measure: Mini-Nutritional Assessment (MNA)
timeFrame: Day 1
measure: Refrigerator Content
timeFrame: Day 1
measure: Oral hygiene tools and maintenance
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Clinic of General, Special care, and Geriatric Dentistry, Center of Dental Medicine, University of Zurich
Study officials:
affiliation: University of Zurich
name: Murali Srinivasan, BDS, MDS, MBA, MAS
role: PRINCIPAL_INVESTIGATOR
References: