None (Healthy adults)
Conditions
Interventions
Ingestion of 2 capsules containing lactoferrin once a day for 8 weeks
Ingestion of 2 capsules not containing lactoferrin once a day for 8 weeks
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Subjects aged between 20 to 65 years old. (2) Subjects who generally take three meals a day. (3) Subject who have more than four teeth possible to examine out of the labial-buccal side of the eight teeth including maxillary right first molar (FDI tooth number 16), maxillary right lateral incisor (12), maxillary left central incisor (21), maxillary left first premolar (24), mandibular left lateral incisor (32), mandibular left first molar (36), mandibular right central incisor (41), and mandibular right first premolar (44). Instead of the subjects as mentioned above, subjects having FDI number 17, 15, 11, 22, 25, 37, 35, 31, 42, and 45 are also applicable. (4) Subjects who have gingivitis or at least one periodontal pocket more than 4 mm depth. (5) Subjects who are not receiving treatment for caries and periodontal disease, and have at least 20 teeth new. (6) Subject who can avoid taking foods containing lactoferrin, those displaying oral health related indication such as a xylitol chewing gum, and supplements. (7) Subjects who received a sufficient explanation of the purpose and contents of this examination, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom of gingivitis on anterior teeth Gingival index Plaque index Probing depth Bleeding on probing | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Sales department
Outcome results
None listed