Mouth Odor on Preventing Pneumonia by Oral Frailty

NCT05987982 | Recruiting

• 1 other identifier: B-ER-111-452
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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.

Conditions

Breathing, Mouth; Pneumonia; Frailty

Keywords

mouth odor; pneumonia; oral bacteria; oral frailty; oral management rehabilitation

Outcome Measures

Primary Outcomes (15)

• 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

Study Arms (3)

Group with oral management

EXPERIMENTAL

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

Group with oral care

EXPERIMENTAL

The investigators taught and monitored patients or caregivers to do oral care after meals and before sleep.

Procedure: Oral care

Group with standard of care

NO INTERVENTION

Only provided oral care education.

Interventions

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.

Group with oral management

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.

Group with oral care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University

Tainan, 704, Taiwan

RECRUITING

MeSH Terms

Conditions

Mouth Breathing; Pneumonia; Frailty

Interventions

Exercise; Oral Hygiene; Dental Care Team

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Lung Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Hygiene; Therapeutics; Preventive Dentistry; Dentistry; Patient Care Team; Patient Care Management; Health Services Administration

Central Study Contacts

Yen-Chin Chen

CONTACT

+886-6-2353535; yenchin2427@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Head Nurse and Clinical Assistant Professor

Model Details: 1. Oral management group: oral exercises and oral care. 2. Oral care group: oral hygiene. 3. Routine group

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 14, 2023
• Study Start: August 14, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

TW (1)