Effectiveness of Oral Management Strategies on Improving Oral Frailty and Oral Bacteria

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

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-23

Study Completion Date

2024-04-30

Brief Summary

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The aim of this study is to examine the effectiveness of nurse-driven oral management for improvements of oral frailty, and oral bacteria pneumonia patients with oral frailty using a randomized controlled trial (RCT) design. Hospitalized pneumonia patients (N = 90) will be randomized into three groups (oral management, oral care, and standard of care). The primary outcomes include the oral frailty measures determined by seven-item included oral hygiene, oral dryness, occlusion force, tongue-lip motor function, tongue pressure, mastication function, and swallowing function. Saliva samples were collected from the oral cavity before the bacterial culture was performed in the laboratory. Oral frailty measures and the presence of bacterial exposure were evaluated at baseline (1st day), on days 5, and at the time of discharge. The investigators will perform statistical analyses according to the intention-to-treat principle. All missing values will be imputed using the last value carry-forward method. The between-group differences will be examined using a mixed model in which group and time interaction will be included. This study finding could provide oral management strategies that could improve oral frailty and decrease oral bacteria for preventing recurrent pneumonia infection among middle-aged and older adults with pneumonia.

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Detailed Description

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The inclusion criteria will be as follows: (1) patients should be ≥ 50 years old; (2) patients' oral frailty should have been diagnosed with pneumonia, and (3) patients should have a Glasgow coma index of 15 points and be able to cooperate. Alternatively, the exclusion criteria will be as follows: (1) people with healthcare-related pneumonia; (2) those with head and neck cancer; or (3) those having an abnormal oral structure.

Conditions

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Oral Hygiene Pneumonia, Bacterial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

90 patients will be recruited and randomly assigned to three groups: the oral care group, the oral management group, and the standard care group.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group with oral care

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

Group Type EXPERIMENTAL

Group with oral care

Intervention Type PROCEDURE

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

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

Group with oral management

Intervention Type PROCEDURE

The investigators provided information on oral health care plus oral exercises before meals, including salivary glands massage methods.

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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Group with oral management

The investigators provided information on oral health care plus oral exercises before meals, including salivary glands massage methods.

Intervention Type PROCEDURE

Group with oral care

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Older than 50 years of age and equal
* Having mental clarity (Glasgow coma scale: 15)

Exclusion Criteria

* A brief hospitalization (≤ 3 days) for non-acute care, such as uncomplicated elective percutaneous coronary intervention;
* Acute psychiatric syndromes;
* Received dental treatment in the last 6 months.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No