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

National Cheng-Kung University

Status: Completed

Conditions: Oral Hygiene; Pneumonia, Bacterial

Treatments: Procedure: Group with oral management; Procedure: Group with oral care

Study type: Interventional

Funder types: Other

Identifiers

NCT05407532

A-ER-110-281

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 55 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

55 participants in 3 patient groups

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: Group with oral care

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: Group with oral management

Group with standard of care

No Intervention group

Description:

Only provided oral care education.