Mouth Odor on Preventing Pneumonia by Oral Frailty

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breathing, Mouth, Pneumonia, Frailty

Intervention / Treatment
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* Procedure: Oral exercises and oral hygiene
* Procedure: Oral care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Oral management group: oral exercises and oral care. Oral care group: oral hygiene. Routine group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group with oral management<br>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<br>* 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.<br>|
| Experimental: Group with oral care<br>The investigators taught and monitored patients or caregivers to do oral care after meals and before sleep. | Procedure: Oral care<br>* 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.<br>|
| No Intervention: Group with standard of care<br>Only provided oral care education. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mouth odor, pneumonia, oral bacteria, oral frailty, oral management rehabilitation