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Mouth Odor on Preventing Pneumonia by Oral Frailty

Mouth Odor as a Precision Care Indicator for Preventing Pneumonia Among Middle-aged and Older Adults With Oral Frailty

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05987982
Enrollment
304
Registered
2023-08-14
Start date
2023-08-14
Completion date
2026-07-31
Last updated
2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breathing, Mouth, Frailty, Pneumonia

Keywords

mouth odor, pneumonia, oral bacteria, oral frailty, oral management rehabilitation

Brief summary

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.

Detailed 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.

Interventions

PROCEDUREOral exercises and oral hygiene

The patients will be required to perform oral exercises and maintain oral hygiene twice a day. The investigators will assess their oral frailty, oral bacteria, oral odor, and other related clinical care data on the following time points: day 1 of hospitalization, day 3 of hospitalization, the day of discharge, one week after discharge, and one month after discharge.

PROCEDUREOral care

The patients will be required to maintain oral hygiene twice a day. The investigators will assess their oral frailty, oral bacteria, oral odor, and other related clinical care data on the following time points: day 1 of hospitalization, day 3 of hospitalization, the day of discharge, one week after discharge, and one month after discharge.

Sponsors

National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

1. Oral management group: oral exercises and oral care. 2. Oral care group: oral hygiene. 3. Routine group

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Oral odorThe first day of admission (baseline)A participant was requested to exhale two gas sampling gas for testing. The investigators uesd an E-nose to identify the participants' odor. To assess the variation of oral odor after different interventions.
Clearance of pneumonia associated oral bacteriaThe first day of admission (baseline)The investigators collected tongue specimens from participants for bacterial isolation and identification. The participants' specimens were collected using an eswab and sent for bacterial culture within 2 hours. Bacterial colonies were quantified (CFU/ml). To observe the variation caused by the number of bacteria, measurements were taken again after the intervention. The investigators assessed the clearance of bacteria based on the baseline.
oral frailty measures (oral functions)The first day of admission (baseline)The investigators measured seven items for patients to identify oral frailty including 1) the number of teeth, 2) masticatory ability, 3) difficulty making the ta sound, 4) tongue pressure, 5) abnormal swallowing pressure, and 6) tongue coating index (TCI), 7) oral dryness. Oral frailty was determined into three groups: non-oral frailty, 0 points; pre-oral frailty, 1-2 points; and oral frailty, ≥ 3 points.

Countries

Taiwan

Contacts

Primary ContactYen-Chin Chen
yenchin2427@gmail.com+886-6-2353535

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026