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NCT Number: NCT05407532

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

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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Key information

Conditions

Oral Hygiene Bacterial Infections Bacterial Infections and Mycoses Infections Lung Diseases Pneumonia Pneumonia, Bacterial Respiratory Tract Diseases Respiratory Tract Infections

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Tainan, Taiwan (r.o.c), 701, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group with oral management

Procedure

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

Group with oral care

Procedure

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

Primary outcomes

  1. oral frailty measures

    Time frame: 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.

  2. Clearance of pneumonia associated oral bacteria

    Time frame: 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.

  3. oral frailty measures

    Time frame: 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.

  4. oral frailty measures

    Time frame: 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.

  5. Clearance of pneumonia associated oral bacteria

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 7, 2022
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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