Confirmation trial about clinical/preventive effects of newly developed toothpaste against periodontal disease
- Conditions
- Healthy male/female volunteers
- Registration Number
- JPRN-UMIN000043228
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
(1) At the screening test, volunteers who were determined as a patient having some dental caries (over C3 level) and/or severe periodontal disease. (2) Volunteers with medical treatment for diabetic, chronic kidney, digestive, lung or cancer diseases. (3) Volunteers having some kind of systemic disease, which has serious difficulty in participating this trial. (4) Volunteers with toothbrushing not less than four times a day, including the brushing before and after breakfast, before their normal bedtime, etc. (5) Pregnant, possibly pregnant, or lactating women, during this clinical trial. (6) Volunteers who are now under the other clinical trials with some kind of medicine/food, or willing to participate in similar tests. (7) Volunteers having their stimulating saliva with no more than 3.0 mL for 5 min. (8) Volunteers having stimulating saliva with no more than a pH of 6.2. (9) Volunteers with some kind of allergy. (10) Volunteers equipped with removable denture, and/or dental implant on the dental object. (11) Volunteers falling into the habit of smoking. (12) Volunteers who have regularly used some kind of health food. (13) Volunteers who have took in some kind of antibiotic and/or antibacterial agent, regularly or within the last month to the screening test. (14) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Gingivitis index 2. Dental plaque index 3. Depth of periodontal pocket
- Secondary Outcome Measures
Name Time Method 1. Swelling 2. Reddening 3. Existence quantification of P. gingivalis / T. forsythia in saliva 4. Free Hb value / LDH activity in saliva 5. Overall effectiveness 6. Concentrations of volatile sulfur compounds, just like H2S and Me3SH 7. IL-1beta / IL-8 activity in saliva