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NCT Number: NCT05987982

Mouth Odor on Preventing Pneumonia by 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.

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Key information

Conditions

Breathing, Mouth Frailty Infections Lung Diseases Mouth Breathing Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory

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, 704, Taiwan

Location status: Recruiting

Location contact

YenChin Chen

CONTACT

[email protected]

+886-6-2353535 ext. 2019

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Oral exercises and oral hygiene

Procedure

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.

Oral care

Procedure

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.

Primary outcomes

  1. Clearance of pneumonia associated oral bacteria

    Time frame: The first day of admission (baseline)

    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.

  2. Clearance of pneumonia associated oral bacteria

    Time frame: Day 3 of admission

    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.

  3. Clearance of pneumonia associated oral bacteria

    Time frame: Discharge day

    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.

  4. Clearance of pneumonia associated oral bacteria

    Time frame: 1-week after discharge day

    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.

  5. Clearance of pneumonia associated oral bacteria

    Time frame: 1-month after discharge day

    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.

  6. oral frailty measures (oral functions)

    Time frame: The first day of admission (baseline)

    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.

  7. oral frailty measures (oral functions)

    Time frame: Day 3 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.

  8. oral frailty measures (oral functions)

    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.

  9. oral frailty measures (oral functions)

    Time frame: 1-week after 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.

  10. oral frailty measures (oral functions)

    Time frame: 1-month after 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.

  11. Oral odor

    Time frame: The first day of admission (baseline)

    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.

  12. Oral odor

    Time frame: Day 3 of admission

    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.

  13. Oral odor

    Time frame: Discharge day

    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.

  14. Oral odor

    Time frame: 1-week after discharge day

    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.

  15. Oral odor

    Time frame: 1-month after discharge day

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yen-Chin Chen

CONTACT

[email protected]

+886-6-2353535 ext. 2019

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2023
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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