Investigation of oral frailty morbidity in Japanese elderly type 2 diabetes

JRCT ID: jRCT1042230041

Registered date:21/06/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Type 2 diabetes mellitus
• Date of first enrollment: 21/06/2023
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Oral functions are evaluated in the dental examination. This includes general intraoral observation, tongue pressure measurement using a tongue depressometer (JMS TPM-02), masticatory function evaluation using a glucose analyzer (Glucosensor GS-IIN), and bite force evaluation using a film for bite force measurement system (Dental Prescale II).
TPM-02 is a tongue pressure measuring instrument consisting of a digital tongue depressometer, a tongue pressure probe, and a connecting tube. The tongue probe is inserted into the oral cavity and the tongue presses the probe against the hard palate to measure tongue pressure.
The GS-IIN glucose sensor is a glucose measuring instrument. After chewing a gummy bear containing glucose for 20 seconds, the spat out filtrate is applied to the sensor chip to measure glucose. As oral function declines, chewing of the gummies becomes insufficient and the glucose concentration declines.
Dental Prescale II is a film for bite force measurement system. After this film is occluded, the film is read by a PC connected to an A4 size scanner. The bite force is then analyzed by software (Bite Force Analyzer) to quantify the occlusal force.

Outcome(s)

Primary Outcome

Prevalence of oral frailty
(Diagnosis is made according to the evaluation methods for oral functional decline defined by the Japanese Association for Dental Science: oral hygiene, oral dryness, bite strength, presence of tongue and oral motor function decline, tongue pressure, presence of masticatory function decline, presence of swallowing function decline, number of remaining teeth, presence of dentures, presence of oral opening disorder, and feeding and swallowing questionnaire [FILS/FOIS])

Secondary Outcome

HbA1c
Percentage of target HbA1c achieved
Blood pressure
Lipid profile
Grip strength
Body weight
Body composition
DASC-8
Barthel index
FFQ
DTR-QOL
GOHAI
Frequency of dental visits
AGE (terminal glycation products)

Key inclusion & exclusion criteria

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

Include criteria

1) Patients with type 2 diabetes admitted to our hospital
2) Patients aged 65 years or over at the time consent is obtained
3) Patients whose consent to participate in the research has been obtained in writing from the individual

Exclude criteria

1) Patients with acute diabetic complications or severe infections
2) Patients who have difficulty following the instructions of the principal investigator or sub-investigator
3) Patients participating in other research.
4) Other patients who are judged by the principal investigator or sub-investigator to be unsuitable for this clinical research.

Related Information

• Primary Sponsor: Yabe Daisuke
• Source(s) of Monetary Support: Japan Association for Diabetes Education and Care