Effectiveness of Oral Management Strategies on Improving Oral Frailty and Oral Bacteria

Pneumonia, Bacterial Clinical Trial

Official title:

Effectiveness of Oral Management Strategies on Improving Oral Frailty and Oral Bacteria Among Middle-aged and Elderly Hospitalized Adults With Pneumonia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05407532
• Other study ID #: A-ER-110-281
• Status: Recruiting
• Phase: N/A
• Start date: December 23, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: National Cheng-Kung University Hospital
• Contact: Yen-Chin Chen, Ph.D.
• Phone: +886-6-2353535
• Email: yenchin2427[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to examine the effectiveness of nurse-driven oral management for improvements of oral frailty, and oral bacteria pneumonia patients with oral frailty using a randomized controlled trial (RCT) design. Hospitalized pneumonia patients (N = 90) will be randomized into three groups (oral management, oral care, and standard of care). The primary outcomes include the oral frailty measures determined by seven-item included oral hygiene, oral dryness, occlusion force, tongue-lip motor function, tongue pressure, mastication function, and swallowing function. Saliva samples were collected from the oral cavity before the bacterial culture was performed in the laboratory. Oral frailty measures and the presence of bacterial exposure were evaluated at baseline (1st day), on days 5, and at the time of discharge. The investigators will perform statistical analyses according to the intention-to-treat principle. All missing values will be imputed using the last value carry-forward method. The between-group differences will be examined using a mixed model in which group and time interaction will be included. This study finding could provide oral management strategies that could improve oral frailty and decrease oral bacteria for preventing recurrent pneumonia infection among middle-aged and older adults with pneumonia.

Description:

The inclusion criteria will be as follows: (1) patients should be ≥ 50 years old; (2) patients' oral frailty should have been diagnosed with pneumonia, and (3) patients should have a Glasgow coma index of 15 points and be able to cooperate. Alternatively, the exclusion criteria will be as follows: (1) people with healthcare-related pneumonia; (2) those with head and neck cancer; or (3) those having an abnormal oral structure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Older than 50 years of age and equal

• Having mental clarity (Glasgow coma scale: 15)

Exclusion Criteria:

• A brief hospitalization (= 3 days) for non-acute care, such as uncomplicated elective percutaneous coronary intervention;

• Acute psychiatric syndromes;

• Received dental treatment in the last 6 months.

Related Conditions & MeSH terms

• Frailty
• Oral Hygiene
• Pneumonia
• Pneumonia, Bacterial

Intervention

Procedure:
• Group with oral management
The investigators provided information on oral health care plus oral exercises before meals, including salivary glands massage methods.
• Group with oral care
The investigators taught and monitored patients or caregivers to do oral care after meals and before sleep.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan	Tainan	Taiwan (r.o.c)

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Chiang TC, Huang MS, Lu PL, Huang ST, Lin YC. The effect of oral care intervention on pneumonia hospitalization, Staphylococcus aureus distribution, and salivary bacterial concentration in Taiwan nursing home residents: a pilot study. BMC Infect Dis. 2020 May 27;20(1):374. doi: 10.1186/s12879-020-05061-z. — View Citation

Minakuchi S, Tsuga K, Ikebe K, Ueda T, Tamura F, Nagao K, Furuya J, Matsuo K, Yamamoto K, Kanazawa M, Watanabe Y, Hirano H, Kikutani T, Sakurai K. Oral hypofunction in the older population: Position paper of the Japanese Society of Gerodontology in 2016. Gerodontology. 2018 Dec;35(4):317-324. doi: 10.1111/ger.12347. Epub 2018 Jun 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oral frailty measures	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 value)
Primary	Clearance of pneumonia associated oral bacteria	The investigators collected participants' gargling water for bacterial isolation and identification. The investigators asked the participant to gargle with 20 ml of N/S for approximately 20 seconds. The standard procedure for gargling was full mouth at least three times. The investigators collected gargling water in a bacterial collection bottle and sent it for bacterial culture within 2 hours. Bacterial colonies were quantified (CFU/ml). To observe the variation due to the different rinse solutions, the number of bacteria was determined again after the intervention. The investigators assessed the clearance of bacteria based on the baseline.	The first day of admission (baseline value)
Primary	oral frailty measures	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 5 of admission
Primary	oral frailty measures	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
Primary	Clearance of pneumonia associated oral bacteria	The investigators collected participants' gargling water for bacterial isolation and identification. The investigators asked the participant to gargle with 20 ml of N/S for approximately 20 seconds. The standard procedure for gargling was full mouth at least three times. The investigators collected gargling water in a bacterial collection bottle and sent it for bacterial culture within 2 hours. Bacterial colonies were quantified (CFU/ml). To observe the variation due to the different rinse solutions, the number of bacteria was determined again after the intervention. The investigators assessed the clearance of bacteria based on the baseline.	Discharge day