Clinical trial NCT06606548: Comprehensive Oral Care Long-term Care Facilities
Official title: The Impact of Comprehensive Oral Care on the Eating Function in Long-term Care Facilities Residents
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dysphagia
Keywords: dysphagia
oral care
nasogastric tube
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oral care is a common way of caring for long-term care facility residents, particularly for those with swallowing difficulties, as oral health is closely related to eating function. Oral care includes general oral hygiene and comprehensive oral care (including cleaning, facial massage, oral muscle massage and stretching, and oral moisturizing). Regular oral care can reduce oral diseases, improve oral mucosa, increase appetite, and improve eating function. However, it is still unclear whether comprehensive oral care can improve eating function and aid in removing nasogastric tubes. Therefore, this study plans to recruit residents with dysphagia from multiple long-term care facilities nationwide to investigate the impact of comprehensive oral care on nasogastric tube removal. The study will collect basic information, disease diagnosis, and onset time and use random grouping to investigate the effects of general oral hygiene and oral care on nasogastric tube removal. The results of this study can provide guidance for clinical practitioners and researchers on oral care and eating function improvement for long-term care facility residents.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older, with swallowing disorders classified as grades 1-3 on the Functional Oral Intake Scale (FOIS).
* Conscious and alert.
* Able to follow simple one-step commands (e.g., raising a hand, opening the mouth).
* Able to maintain a seated position for more than 15 minutes.
* Has a swallowing reflex (able to swallow saliva on command).

Exclusion Criteria:

* Acute infection.
* Hypoxemia (SaO2 \< 90%) or requiring the use of a ventilator.
* Structural abnormalities of the oropharyngeal area that prevent oral feeding.
* Failing the water swallow test (coughing or wet voice in two or more out of three attempts, or no significant laryngeal elevation).

Primary outcomes:
measure: Removing nasogastric tubes
timeFrame: Follow up for 6 months
Secondary outcomes:
measure: the functional oral intake scale
timeFrame: Follow up for 6 months
measure: body weight
timeFrame: Follow up for 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongzheng Dist.
Study officials:
affiliation: +886-2312-3456
name: Ming-Yen Hsiao, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Porter J, Ntouva A, Read A, Murdoch M, Ola D, Tsakos G. The impact of oral health on the quality of life of nursing home residents. Health Qual Life Outcomes. 2015 Jul 15;13:102. doi: 10.1186/s12955-015-0300-y.
citation: Kenny A, Dickson-Swift V, Chan CKY, Masood M, Gussy M, Christian B, Hodge B, Furness S, Hanson LC, Clune S, Zadow E, Knevel RJ. Oral health interventions for older people in residential aged care facilities: a protocol for a realist systematic review. BMJ Open. 2021 May 5;11(5):e042937. doi: 10.1136/bmjopen-2020-042937.
citation: Barbe AG, Kupeli LS, Hamacher S, Noack MJ. Impact of regular professional toothbrushing on oral health, related quality of life, and nutritional and cognitive status in nursing home residents. Int J Dent Hyg. 2020 Aug;18(3):238-250. doi: 10.1111/idh.12439. Epub 2020 May 11.