- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06606548
Comprehensive Oral Care Long-term Care Facilities
November 17, 2025 updated by: National Taiwan University Hospital
The Impact of Comprehensive Oral Care on the Eating Function in Long-term Care Facilities Residents
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
91
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhongzheng Dist.
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Taipei, Zhongzheng Dist., Taiwan, 100
- National Taiwan University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: general oral hygiene
|
|
|
Experimental: comprehensive oral care
including cleaning, facial massage, oral muscle massage and stretching, and oral moisturizing.
|
including cleaning, facial massage, oral muscle massage and stretching, and oral moisturizing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Removing nasogastric tubes
Time Frame: Follow up for 6 months
|
Each subject was tracked at one month, three months, and six months for the status of their nasogastric tube.
|
Follow up for 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the functional oral intake scale
Time Frame: Follow up for 6 months
|
Follow up for 6 months
|
|
body weight
Time Frame: Follow up for 6 months
|
Follow up for 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ming-Yen Hsiao, PHD, +886-2312-3456
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 25, 2023
Primary Completion (Actual)
November 29, 2023
Study Completion (Actual)
May 24, 2025
Study Registration Dates
First Submitted
June 13, 2024
First Submitted That Met QC Criteria
September 18, 2024
First Posted (Actual)
September 23, 2024
Study Record Updates
Last Update Posted (Actual)
November 18, 2025
Last Update Submitted That Met QC Criteria
November 17, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202305043RINC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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