NCT06606548

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2025

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

June 13, 2024

Last Update Submit

November 17, 2025

Conditions

Dysphagia

Keywords

dysphagiaoral carenasogastric tube

Outcome Measures

Primary Outcomes (1)

  • Removing nasogastric tubes

    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 Outcomes (2)

  • the functional oral intake scale

    Follow up for 6 months

  • body weight

    Follow up for 6 months

Study Arms (2)

general oral hygiene

NO INTERVENTION

comprehensive oral care

EXPERIMENTAL

including cleaning, facial massage, oral muscle massage and stretching, and oral moisturizing.

Behavioral: comprehensive oral care

Interventions

comprehensive oral careBEHAVIORAL

including cleaning, facial massage, oral muscle massage and stretching, and oral moisturizing.

comprehensive oral care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhongzheng Dist., 100, Taiwan

Location

Related Publications (3)

  • 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.

    PMID: 26169066RESULT

  • 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.

    PMID: 33952539RESULT

  • 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.

    PMID: 32329175RESULT

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Ming-Yen Hsiao, PHD

    +886-2312-3456

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2024

First Posted

September 23, 2024

Study Start

May 25, 2023

Primary Completion

November 29, 2023

Study Completion

May 24, 2025

Last Updated

November 18, 2025

Record last verified: 2025-11

Locations

TW(1)