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

Sponsor

National Cheng-Kung University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05407532

Collaborator

(none)

Enrollment

Location

Arms

12.3

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Hygiene Pneumonia, Bacterial	Procedure: Group with oral management Procedure: Group with oral care	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

Effectiveness of Oral Management Strategies on Improving Oral Frailty and Oral Bacteria Among Middle-aged and Elderly Hospitalized Adults With Pneumonia

Actual Study Start Date :

Dec 23, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group with oral care The investigators taught and monitored patients or caregivers to do oral care after meals and before sleep.	Procedure: Group with oral care The investigators taught and monitored patients or caregivers to do oral care after meals and before sleep.
Experimental: 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.	Procedure: Group with oral management The investigators provided information on oral health care plus oral exercises before meals, including salivary glands massage methods.
No Intervention: Group with standard of care Only provided oral care education.

Arm

Intervention/Treatment

Experimental: Group with oral care

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

Procedure: Group with oral care

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

Experimental: 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.

Procedure: Group with oral management

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

No Intervention: Group with standard of care

Only provided oral care education.

Outcome Measures

Primary Outcome Measures

oral frailty measures [The first day of admission (baseline value)]
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.
Clearance of pneumonia associated oral bacteria [The first day of admission (baseline value)]
The investigators collected participants' gargling water for bacterial isolation and identification. The investigators asked the participant to gargle with 20 ml of N/S for approximately 20 seconds. The standard procedure for gargling was full mouth at least three times. The investigators collected gargling water in a bacterial collection bottle and sent it for bacterial culture within 2 hours. Bacterial colonies were quantified (CFU/ml). To observe the variation due to the different rinse solutions, the number of bacteria was determined again after the intervention. The investigators assessed the clearance of bacteria based on the baseline.
oral frailty measures [Day 5 of admission]
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.
oral frailty measures [Discharge day]
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.
Clearance of pneumonia associated oral bacteria [Discharge day]
The investigators collected participants' gargling water for bacterial isolation and identification. The investigators asked the participant to gargle with 20 ml of N/S for approximately 20 seconds. The standard procedure for gargling was full mouth at least three times. The investigators collected gargling water in a bacterial collection bottle and sent it for bacterial culture within 2 hours. Bacterial colonies were quantified (CFU/ml). To observe the variation due to the different rinse solutions, the number of bacteria was determined again after the intervention. The investigators assessed the clearance of bacteria based on the baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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.