Investigation of the Effect of High Viscosity Mouthwash on Oral Function Improvement

JRCT ID: jRCTs072220032

Registered date:29/07/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Oral hypofunction
• Date of first enrollment: 08/02/2023
• Target sample size: 24
• Study type: Interventional

Intervention(s)

Explanations will be provided to eligible patients who meet the registration requirements, and written consent will be obtained.
1. Baseline assessment of lip closure (Lip Decam)
2. Mouthwash will be used 3 times a day (after each meal) for 4 weeks, measure the same items as at baseline.
3. Other evaluations (tongue pressure, occlusal pressure, chewing ability, swallowing function, degree of tongue coating, degree of xerostomia, oral dryness, oral diadochokinesis, subjective evaluation)

Outcome(s)

• Primary Outcome: Lip closure after 1 month of use (Lip Decam measurements)

Secondary Outcome

Tongue pressure after 1 month of use (JMS tongue depressometer measurements)
Occlusal pressure after 1 month of use (dental prescale measurements)
Chewing ability after 1 month of use (Glucosensor measurements)
Swallowing function after 1 month of use (EAT-10)
Degree of tongue coating after 1 month of use(TCI)
Oral dryness after 1 month of use(mucus measurements)
Oral diadochokinesis after 1 month of use(Kenkoukun measurements)
Adverse events after 1 month of use(Inflammatory changes such as redness and swelling of lips and lip mucosa)
Subjective evaluation after 1 month of use(Mouthwash Usage Questionnaire)
Patient Background(Age, gender, dental formula, medication status)
Number of mouthwash pouches after use

Key inclusion & exclusion criteria

• Age minimum: >= 70age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following criteria will be considered
(1) Age: Patients whose age is 70 years or older at the time of obtaining consent
(2) Patients who are aware of spilling food within the past 3 months,or those who do not meet the standard value (6.0 times/second) for the /pa/ sound of aural diadochokinesis.
(3) Those with all upper and lower anterior teeth remaining (Including missing prosthesis in crown bridge dentures)
(4)Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on a thorough understanding of the study

Exclude criteria

Patients with any one of the following will be excluded from coverage
(1) Patients who are judged to lack the ability to make decisions(Less than 27 points on the dementia screening test(Mini-Mental State Examination))
(2) Patients at high risk of aspiration (Total score of 3 or more points on the swallowing screening tool (EAT-10))
(3) Patients who have a defective part without a prosthetic device
(4) Those who use mouthwash regularly
(5) Those who have a history of allergy to the ingredients in the mouthwash
(6) Other patients who are judged by the principalinvestigator or sub-investigator to be inappropriate as research subjects

Related Information

• Primary Sponsor: Kusunoki Takayuki
• Secondary Sponsor: Takahashi Kazuya,SUNSTAR INC.