A verification study of improving on the oral cavity environment with consumption of the test food
- Conditions
- periodontosis
- Registration Number
- JPRN-jRCTs031190204
- Lead Sponsor
- Horiuchi Masahiko
- Brief Summary
The log-transformed value of T.forsythensis after 4 weeks of intake, the primary outcome of this study, was significantly lower in the test food group than in the placebo group. In addition, there was a significant decrease in the total bacteria counts, A. actinomycetemcomitans, and P. intermedia. Therefore, the continuous intake of the test food for 4 weeks was shown to be useful in reducing periodontal disease-associated bacteria.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
1. Japanese males and females
2. Subjects who are diagnosed with periodontosis
3. Subjects who are judged as eligible to participate in the trial by the principal investigator
4. Subjects who have relatively high percentage of T. forsythensis in salivary test at the screening
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
- Secondary Outcome Measures
Name Time Method