Mouth Odor on Preventing Pneumonia by Oral Frailty

Mouth Odor as a Precision Care Indicator for Preventing Pneumonia Among Middle-aged and Older Adults With Oral Frailty

This research plan aims to first collect data on the oral function and oral hygiene status of the elderly population in the community and to understand the normal model of oral frailty among the older adults in the community. Subsequently, a comparison will be made between the oral status of hospitalized patients and the community-dwelling elderly population. The goal is to verify whether oral odor can be used as an objective biological indicator following intervention.

Study Overview

• Status: Recruiting
• Conditions: Pneumonia; Frailty; Breathing, Mouth
• Intervention / Treatment: Procedure: Oral exercises and oral hygiene; Procedure: Oral care

Detailed Description

The first stage will aim to examine the relationships between the level of oral frailty and pneumonia-associated pathogens, as well as to establish a mouth odor database among community-dwelling people; The second stage will compare the differences of the level of oral frailty, pneumonia associated pathogens, and mouth odor between 144 middle-aged and older healthy people and 160 hospitalization patients. The third stage will confirm whether the mouth odor is an effective biological maker to show the changes of oral frailty, pneumonia-associated pathogens, and mouth odor after oral management rehabilitation.

• Study Type: Interventional
• Enrollment (Estimated): 304
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yen-Chin Chen; Phone Number: 2019 +886-6-2353535; Email: yenchin2427@gmail.com

Study Locations

• Taiwan
  • Tainan City, Taiwan, 704
    • Recruiting
    • National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University
    • Contact: YenChin Chen; Phone Number: 2019 +886-6-2353535; Email: yenchin2427@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age ≥ 50 years old,
• Alert and oriented,
• With sufficient comprehension and cooperation,
• Willing to participate in oral assessment.

Exclusion Criteria:

• Patients who score below 5 on the General Practitioner Assessment of Cognition (GPCOG),
• Patients with oral treatments such as oral cancer treatment,
• Patients with oral treatments such as periodontal disease treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

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: Oral care; The patients will be required to maintain oral hygiene twice a day. The investigators will assess their oral frailty, oral bacteria, oral odor, and other related clinical care data on the following time points: day 1 of hospitalization, day 3 of hospitalization, the day of discharge, one week after discharge, and one month after discharge.
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: Oral exercises and oral hygiene; The patients will be required to perform oral exercises and maintain oral hygiene twice a day. The investigators will assess their oral frailty, oral bacteria, oral odor, and other related clinical care data on the following time points: day 1 of hospitalization, day 3 of hospitalization, the day of discharge, one week after discharge, and one month after discharge.
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
Clearance of pneumonia associated oral bacteria	The investigators collected tongue specimens from participants for bacterial isolation and identification. The participants' specimens were collected using an eswab and sent for bacterial culture within 2 hours. Bacterial colonies were quantified (CFU/ml). To observe the variation caused by the number of bacteria, measurements were taken again after the intervention. The investigators assessed the clearance of bacteria based on the baseline.	The first day of admission (baseline)
Clearance of pneumonia associated oral bacteria	The investigators collected tongue specimens from participants for bacterial isolation and identification. The participants' specimens were collected using an eswab and sent for bacterial culture within 2 hours. Bacterial colonies were quantified (CFU/ml). To observe the variation caused by the number of bacteria, measurements were taken again after the intervention. The investigators assessed the clearance of bacteria based on the baseline.	Day 3 of admission
Clearance of pneumonia associated oral bacteria	The investigators collected tongue specimens from participants for bacterial isolation and identification. The participants' specimens were collected using an eswab and sent for bacterial culture within 2 hours. Bacterial colonies were quantified (CFU/ml). To observe the variation caused by the number of bacteria, measurements were taken again after the intervention. The investigators assessed the clearance of bacteria based on the baseline.	Discharge day
Clearance of pneumonia associated oral bacteria	The investigators collected tongue specimens from participants for bacterial isolation and identification. The participants' specimens were collected using an eswab and sent for bacterial culture within 2 hours. Bacterial colonies were quantified (CFU/ml). To observe the variation caused by the number of bacteria, measurements were taken again after the intervention. The investigators assessed the clearance of bacteria based on the baseline.	1-week after discharge day
Clearance of pneumonia associated oral bacteria	The investigators collected tongue specimens from participants for bacterial isolation and identification. The participants' specimens were collected using an eswab and sent for bacterial culture within 2 hours. Bacterial colonies were quantified (CFU/ml). To observe the variation caused by the number of bacteria, measurements were taken again after the intervention. The investigators assessed the clearance of bacteria based on the baseline.	1-month after discharge day
oral frailty measures (oral functions)	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)
oral frailty measures (oral functions)	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 3 of admission
oral frailty measures (oral functions)	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
oral frailty measures (oral functions)	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.	1-week after discharge day
oral frailty measures (oral functions)	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.	1-month after discharge day
Oral odor	A participant was requested to exhale two gas sampling gas for testing. The investigators uesd an E-nose to identify the participants' odor. To assess the variation of oral odor after different interventions.	The first day of admission (baseline)
Oral odor	A participant was requested to exhale two gas sampling gas for testing. The investigators uesd an E-nose to identify the participants' odor. To assess the variation of oral odor after different interventions.	Day 3 of admission
Oral odor	A participant was requested to exhale two gas sampling gas for testing. The investigators uesd an E-nose to identify the participants' odor. To assess the variation of oral odor after different interventions.	Discharge day
Oral odor	A participant was requested to exhale two gas sampling gas for testing. The investigators uesd an E-nose to identify the participants' odor. To assess the variation of oral odor after different interventions.	1-week after discharge day
Oral odor	A participant was requested to exhale two gas sampling gas for testing. The investigators uesd an E-nose to identify the participants' odor. To assess the variation of oral odor after different interventions.	1-month after discharge day

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

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: oral bacteria; pneumonia; oral frailty; mouth odor; oral management rehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Signs and Symptoms, Respiratory; Pneumonia; Frailty; Mouth Breathing
• Other Study ID Numbers: B-ER-111-452

Drug and device information, study documents

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