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

NCT05407532 | Completed

• 1 other identifier: A-ER-110-281
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Hygiene; Pneumonia, Bacterial

Keywords

Pneumonia; Oral frailty; Oral bacteria; Oral management

Outcome Measures

Primary Outcomes (5)

• oral frailty measures

  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.

  The first day of admission (baseline value)

• Clearance of pneumonia associated oral bacteria

  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.

  The first day of admission (baseline value)

• oral frailty measures

  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.

  Day 5 of admission

• oral frailty measures

  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.

  Discharge day

• Clearance of pneumonia associated oral bacteria

  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.

  Discharge day

Study Arms (3)

Group with oral care

EXPERIMENTAL

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

Procedure: Group with oral care

Group with oral management

EXPERIMENTAL

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

Group with standard of care

NO INTERVENTION

Only provided oral care education.

Interventions

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 management

Group with oral care PROCEDURE

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

Group with oral care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

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

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

Location

Related Publications (2)

• Chiang TC, Huang MS, Lu PL, Huang ST, Lin YC. The effect of oral care intervention on pneumonia hospitalization, Staphylococcus aureus distribution, and salivary bacterial concentration in Taiwan nursing home residents: a pilot study. BMC Infect Dis. 2020 May 27;20(1):374. doi: 10.1186/s12879-020-05061-z.

  PMID: 32460697 BACKGROUND

• Minakuchi S, Tsuga K, Ikebe K, Ueda T, Tamura F, Nagao K, Furuya J, Matsuo K, Yamamoto K, Kanazawa M, Watanabe Y, Hirano H, Kikutani T, Sakurai K. Oral hypofunction in the older population: Position paper of the Japanese Society of Gerodontology in 2016. Gerodontology. 2018 Dec;35(4):317-324. doi: 10.1111/ger.12347. Epub 2018 Jun 8.

  PMID: 29882364 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Bacterial; Pneumonia

Interventions

Population Groups; Therapeutics

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• I-Yin Ho

  National Cheng-Kung University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Head Nurse and Clinical Assistant Professor

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

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: June 7, 2022
• Study Start: December 23, 2021
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

TW (1)