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Mouth Odor on Preventing Pneumonia by Oral Frailty

N

National Cheng-Kung University

Status

Enrolling

Conditions

Breathing, Mouth
Frailty
Pneumonia

Treatments

Procedure: Oral exercises and oral hygiene
Procedure: Oral care

Study type

Interventional

Funder types

Other

Identifiers

NCT05987982
B-ER-111-452

Details and patient eligibility

About

This research plan aims to first collect data on the oral function and oral hygiene status of the elderly population in the community and to understand the normal model of oral frailty among the older adults in the community. Subsequently, a comparison will be made between the oral status of hospitalized patients and the community-dwelling elderly population. The goal is to verify whether oral odor can be used as an objective biological indicator following intervention.

Full description

The first stage will aim to examine the relationships between the level of oral frailty and pneumonia-associated pathogens, as well as to establish a mouth odor database among community-dwelling people; The second stage will compare the differences of the level of oral frailty, pneumonia associated pathogens, and mouth odor between 144 middle-aged and older healthy people and 160 hospitalization patients. The third stage will confirm whether the mouth odor is an effective biological maker to show the changes of oral frailty, pneumonia-associated pathogens, and mouth odor after oral management rehabilitation.

Enrollment

304 estimated patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age ≥ 50 years old,
  • Alert and oriented,
  • With sufficient comprehension and cooperation,
  • Willing to participate in oral assessment.

Exclusion criteria

  • Patients who score below 5 on the General Practitioner Assessment of Cognition (GPCOG),
  • Patients with oral treatments such as oral cancer treatment,
  • Patients with oral treatments such as periodontal disease treatment.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

304 participants in 3 patient groups

Group with oral management
Experimental group
Description:
The investigators taught and monitored patients or caregivers to oral health care plus oral exercises such as salivary glands massage methods after meals and before sleep.
Treatment:
Procedure: Oral exercises and oral hygiene
Group with oral care
Experimental group
Description:
The investigators taught and monitored patients or caregivers to do oral care after meals and before sleep.
Treatment:
Procedure: Oral care
Group with standard of care
No Intervention group
Description:
Only provided oral care education.

Trial contacts and locations

1

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Central trial contact

Yen-Chin Chen

Data sourced from clinicaltrials.gov

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