DysphagiaNCT06606548
Comprehensive Oral Care Long-term Care Facilities
A study testing comprehensive oral care in people with Dysphagia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- comprehensive oral care
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 May 2023to 24 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Dysphagia
- Being tested
- comprehensive oral care
- Keywords
- dysphagia, oral care, nasogastric tube
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comprehensive oral careBehavioural
including cleaning, facial massage, oral muscle massage and stretching, and oral moisturizing.
| Study group | Role | What they receive |
|---|---|---|
| general oral hygiene | No intervention | Not described |
| comprehensive oral care | Experimental | including cleaning, facial massage, oral muscle massage and stretching, and oral moisturizing. Receives: Behavioral: comprehensive oral care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Removing nasogastric tubes
Each subject was tracked at one month, three months, and six months for the status of their nasogastric tube.
Measured: Follow up for 6 months
Secondary outcomes (2)
the functional oral intake scale
Measured: Follow up for 6 months
body weight
Measured: Follow up for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start25 May 2023
- Primary completion29 Nov 2023
- Study completion24 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-Yen Hsiao, PHD, Principal investigator, +886-2312-3456
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606548
- Sponsor's protocol ID
- 202305043RINC
- Status last verified
- Nov 2025
- First submitted
- 13 Jun 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 26169066Kenny 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.
PubMed 33952539Barbe 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.
PubMed 32329175
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Comprehensive Oral Care on the Eating Function in Long-term Care Facilities Residents
- ClinicalTrials.gov ID
- NCT06606548
- Acronym / sponsor ID
- 202305043RINC
- Conditions
- Dysphagia
- Keywords
- dysphagia, oral care, nasogastric tube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 24 May 2025 (actual)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| general oral hygiene | No intervention | – |
| comprehensive oral care | Experimental | Behavioral: comprehensive oral careincluding cleaning, facial massage, oral muscle massage and stretching, and oral moisturizing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comprehensive oral careincluding cleaning, facial massage, oral muscle massage and stretching, and oral moisturizing. | Behavioural | comprehensive oral care |
Primary outcome
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.
2 secondary outcomes
the functional oral intake scale
Time frame: Follow up for 6 months
body weight
Time frame: Follow up for 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Results publication: PubMed 26169066Porter 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.
- Results publication: PubMed 33952539Kenny 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.
- Results publication: PubMed 32329175Barbe 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.
Related trials for Dysphagia
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Active, not recruitingObservational study
Dexmedetomidine Nasal Spray and Postoperative Sore Throat After Bronchoscopy
Postoperative Sore Throat, Bronchoscopy
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
Brief Resolved Unexplained Event, Apparent Life Threatening Event
Enrolling by invitation
Non-invasive Markers of Esophageal Function in Adults
Dysphagia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Yen Hsiao, PHD principal investigator
+886-2312-3456
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comprehensive oral care in people with Dysphagia, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Removing nasogastric tubes (time frame: Follow up for 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06606548, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025; AzTrials last refreshed its copy on 2 Nov 2026.