Mouth Odor on Preventing Pneumonia by Oral Frailty

Sponsor
National Cheng-Kung University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05987982
Collaborator
(none)
304
1
3
35.5
8.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Oral exercises and oral hygiene
  • Procedure: Oral care
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
304 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Oral management group: oral exercises and oral care. Oral care group: oral hygiene. Routine groupOral management group: oral exercises and oral care. Oral care group: oral hygiene. Routine group
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Mouth Odor as a Precision Care Indicator for Preventing Pneumonia Among Middle-aged and Older Adults With Oral Frailty
Anticipated Study Start Date :
Aug 14, 2023
Anticipated Primary Completion Date :
Jul 31, 2026
Anticipated Study Completion Date :
Jul 31, 2026

Arms and Interventions

Arm Intervention/Treatment
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.

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.

No Intervention: Group with standard of care

Only provided oral care education.

Outcome Measures

Primary Outcome Measures

  1. Clearance of pneumonia associated oral bacteria [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 [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 [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 [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 [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) [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) [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) [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) [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) [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University Tainan City Taiwan 704

Sponsors and Collaborators

  • National Cheng-Kung University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chen, Yen-Chin, Vice Head Nurse and Clinical Assistant Professor, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:
NCT05987982
Other Study ID Numbers:
  • B-ER-111-452
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 15, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chen, Yen-Chin, Vice Head Nurse and Clinical Assistant Professor, National Cheng-Kung University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 15, 2023