Mouth Odor on Preventing Pneumonia by Oral Frailty

NCT ID: NCT05987982

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-14

Study Completion Date

2026-07-31

Brief Summary

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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

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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.

Conditions

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Breathing, Mouth Pneumonia Frailty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group with oral management

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.

Group Type EXPERIMENTAL

Oral exercises and oral hygiene

Intervention Type PROCEDURE

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.

Group with oral care

The investigators taught and monitored patients or caregivers to do oral care after meals and before sleep.

Group Type EXPERIMENTAL

Oral care

Intervention Type PROCEDURE

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.

Group with standard of care

Only provided oral care education.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Oral 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.

Intervention Type PROCEDURE

Oral 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chen, Yen-Chin

Vice Head Nurse and Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University

Tainan City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yen-Chin Chen

Role: CONTACT

+886-6-2353535 ext. 2019

Facility Contacts

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YenChin Chen

Role: primary

+886-6-2353535 ext. 2019

Other Identifiers

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B-ER-111-452

Identifier Type: -

Identifier Source: org_study_id

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