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

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

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia, Bacterial; Oral Hygiene
• Intervention / Treatment: Procedure: Group with oral care; Procedure: Group with oral management

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taiwan (r.o.c)
    • Tainan, Taiwan (r.o.c), Taiwan, 701
      • National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital
• Investigators: Study Chair: I-Yin Ho, National Cheng-Kung University Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2021
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: June 2, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 20, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Pneumonia; Oral bacteria; Oral frailty; Oral management
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia; Frailty; Pneumonia, Bacterial
• Other Study ID Numbers: A-ER-110-281

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No