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

Effects of consumption of the test food on the oral cavity in healthy subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study - Effects of consumption of the test food on the oral cavity in healthy subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000047901
Enrollment
50
Registered
2022-06-01
Start date
2022-06-02
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

Healthy Japanese subjects

Interventions

Duration: Three days Test food: Oral care supplement 1 (regular amount) Administration: Take one tablet three times a day after every meals (breakfast, lunch, and dinner) *Take the test food with

Sponsors

ORTHOMEDICO Inc.
Lead Sponsor
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic Medical Corporation Yuseikai, Horiuchi Dental Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
PlI (plaque index)

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

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