A verification study of improving on the oral cavity environment with consumption of the test food

Not Applicable

• Conditions: Periodontosis

• Registration Number: JPRN-UMIN000039501
• Lead Sponsor: ORTHOMEDICO Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-17
• Study Completion: 2020-07-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

1. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction 2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, metabolic syndrome, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage as part of their daily intake 5. Subjects currently regularly taking medications (including herbal medicines) and supplements 6. Subjects who regularly use floss, interdental cleaner, and mouthwash 7. Subjects who have receiving dental maintenance care at dental clinic, such as removing dental plaques and dental tartars within the last three months 8. Subjects who are under treatment or diagnosed with any of dental diseases except for periodontosis 9. Subjects who are smokers, or started smoking cessation within a year before the invitation to participate in this trial 10. Subjects allergic to medications and/or the test-food-related products. Particularly, rye, wheat, oats, corn, rice, and soybean allergies. 11. Subjects who are lactating, pregnant, or intending to become pregnant 12. Subjects who have been enrolled in other clinical trials within the last three months before the invitation to participate in this trial, or plan to participate in another trial during this trial 13. Subjects who are judged by the principal investigator as ineligible to participate in the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The measured values of T.forsythensis at four weeks after the start of test-food consumption (4w) 2. The logarithmic values of T.forsythensis at 4w 3. The ratio of T.forsythensis to total bacteria at 4w 4. The amount of changes in items 1 to 3 above from before intake to 4w

Secondary Outcome Measures

Name	Time	Method
1. The measured values, logarithmic values, and the ratio to total bacteria of A.actinomycetemcomitans, P.gingivalis, P.intermedia, T.denticola, F.nucleatum and the amount of changes of these items from before intake to 4w. 2. The measured values and changes of "halitosis," "swelling of gums," "surface roughness of tooth," "oral discomfort," "dry mouth," "stickiness in the mouth," "eye fatigue," and "blurred eyes" at 4w 3. The measured values and changes of serum and salivary IGF-1 levels at 4w 4. The measured values and changes of the number of S.mutans at 4w 5. The measured values and changes of Gingival Index and Plaque Index at 4w 6. The measured values and changes of bleeding on probing at 4w 7. The measured values and changes of depth of periodontal pockets at 4w 8. The measured values and changes of visual acuities of the average of both eyes and dominant/non-dominant eyes at 4w