The study to confirm the effect of a food containing lactoferrin on oral environment : A randomized, double-blind, placebo controlled trial.
- Conditions
- one (Healthy adults)
- Registration Number
- JPRN-UMIN000039691
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
(1) Subject who are diagnosed with caries (C3<=) or severe periodontal disease. (2) Subject who have illness such as diabetes, chronic kidney disease, gastrointestinal disease, lung disease, malignant tumor and so on, and are taking medicine. (3) Subjects who are pregnant, or who are planning to become pregnant or breast-feeding during the test. (4)Persons who are participating or intend to participate in other tests for taking foods, drugs, and/or cosmetics. (5) Subject whose saliva secretion by stimulation during 5 minutes is less than 3.0 mL. (6) Subjects whose pH of saliva is <= 6.2. (7) Subjects who have food allergy. (8) Subjects who are wearing removal dentures. (9) Subjects who are taking antibiotics and/or anti-microbe agents, or who had taken them within one month prior to the screening test. (10) Smoker (11) Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Symptom of gingivitis on anterior teeth Gingival index Plaque index Probing depth Bleeding on probing
- Secondary Outcome Measures
Name Time Method Saliva test:Hb Saliva,LD Saliva,Saliva Secretion,pH Periodontal bacteria number in Saliva(P.gingivalis,P.intermedia,T.forsythensis,T.denticola) Caries-related bacteria number(total Streptococcus,S.mutans,Lactobacillus) Exploratory endpoint Saliva test:Immune index(IL1,IL6,IL8,TNFalpha)