Clinical trial NCT05987982: Mouth Odor on Preventing Pneumonia by Oral Frailty
Official title: Mouth Odor as a Precision Care Indicator for Preventing Pneumonia Among Middle-aged and Older Adults With Oral Frailty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breathing, Mouth
Pneumonia
Frailty
Keywords: mouth odor
pneumonia
oral bacteria
oral frailty
oral management rehabilitation
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 304
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Oral management group: oral exercises and oral care.
2. Oral care group: oral hygiene.
3. Routine group
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clearance of pneumonia associated oral bacteria
timeFrame: The first day of admission (baseline)
measure: Clearance of pneumonia associated oral bacteria
timeFrame: Day 3 of admission
measure: Clearance of pneumonia associated oral bacteria
timeFrame: Discharge day
measure: Clearance of pneumonia associated oral bacteria
timeFrame: 1-week after discharge day
measure: Clearance of pneumonia associated oral bacteria
timeFrame: 1-month after discharge day
measure: oral frailty measures (oral functions)
timeFrame: The first day of admission (baseline)
measure: oral frailty measures (oral functions)
timeFrame: Day 3 of admission
measure: oral frailty measures (oral functions)
timeFrame: Discharge day
measure: oral frailty measures (oral functions)
timeFrame: 1-week after discharge day
measure: oral frailty measures (oral functions)
timeFrame: 1-month after discharge day
measure: Oral odor
timeFrame: The first day of admission (baseline)
measure: Oral odor
timeFrame: Day 3 of admission
measure: Oral odor
timeFrame: Discharge day
measure: Oral odor
timeFrame: 1-week after discharge day
measure: Oral odor
timeFrame: 1-month after discharge day
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University
Study officials:
References: