MedPath

Effects of consumption of the test food on the oral cavity in healthy subjects

Not Applicable
Conditions
Healthy Japanese subjects
Registration Number
JPRN-UMIN000047901
Lead Sponsor
ORTHOMEDICO Inc.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
55
Inclusion Criteria

Not provided

Exclusion Criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactation, or planning to become pregnant 8. Subjects who suffer from COVID-19 9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 10. Subjects who are judged as ineligible to participate in the study by the physician 11. Subjects who use artificial tooth, post crowns, dentures, implants or bridges 12. Subjects who regularly use gargle medicine, dentifrice, medicated toothpaste, floss, interdental brush, and mouthwash 13. Subjects who have a medical history or current history of Sjogren's syndrome, or who are suspected it 14. Subjects who have diseases associated with salivary gland such as dry mouse and salivary stone disease 15. Subjects who are undergoing medical treatment for periodontosis or dental caries 16. Subjects who are dental treatment or have dental diseases 17. Subjects who are smokers, or started smoking cessation within one year before the agreement to participate in this trial

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
PlI (plaque index)
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath