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

Investigation of the Effect of a Highly Viscous Mouthwash Containing Polysaccharide Thickener on the Improvement of Oral Function

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs072220032
Enrollment
24
Registered
2022-07-29
Start date
2023-02-08
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral hypofunction Decreased lip closure strength

Interventions

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

Sponsors

Kusunoki Takayuki
Lead Sponsor
Takahashi Kazuya
Collaborator
SUNSTAR INC.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Lip closure after 1 month of use (Lip Decam measurements)

Secondary

MeasureTime frame
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

Contacts

Public ContactTakayuki Kusunoki

OSAKA DENTAL UNIVERSITY HOSPITAL

kusunoki@cc.osaka-dent.ac.jp+81-6-6910-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026