An Exploratory Study Evaluating the Preventive Effect of MA-T Mouth Clean Gel Oral Care on Aspiration Pneumonia.

JRCT ID: jRCT1040240140

Registered date:10/12/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Aspiration pneumonia
• Date of first enrollment: 10/12/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Oral care using MA-T Mouth Clean Gel (MA-T [Matching Transformation System]).

Outcome(s)

• Primary Outcome: Number of incidents of aspiration pneumonia

Secondary Outcome

(1) Analysis of the bacterial flora using tongue swabs before and after intervention
(2) Adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Subjects with documented history of aspiration pneumonia two or more times in the past year prior to obtaining consent.
(2) Subjects aged 65 or older at the time of obtaining consent.
(3) Subjects who are receiving outpatient, home-based, or visiting medical care.
(4) Subjects who are able to use the MA-T Mouse Clean Gel or regular toothpaste.

Exclude criteria

(1) Subjects with allergies to the components of the investigational product.
(2) Subjects for whom a one-year follow-up is deemed difficult.
(3) Others deemed unsuitable by the attending physician.

Related Information

• Primary Sponsor: Horiguchi Takahiko
• Source(s) of Monetary Support: ANZU no MORI FOUNDATION