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Examination of the Effects of Food Consumption on Oral Environment Improvement

Examination of the Effects of Food Consumption on Oral Environment Improvement - Examination of the Effects of Food Consumption on Oral Environment Improvement

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000053452
Enrollment
30
Registered
2024-01-26
Start date
2024-01-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male/female adults

Interventions

Take 1 tablet of the test food Take 1 tablet of the control food

Sponsors

EP Mediate Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese men and women aged 40 to below 65 years at the time of consent acquisition 2. Subjects with concerns about their oral environment 3. Preliminary examination will be conducted on 60 subjects, and those with high scores for "Cariogenic bacteria" and "Leukocyte" in the oral and saliva tests at the time of pre-test will be preferentially included. 4. Subjects who fully understand the purpose and content of the research and voluntarily agree to participate in the research

Exclusion criteria

Exclusion criteria: 1. Subjects who have visited a dentist within 10 days prior to the pre-test, those who are currently visiting a dentist for treatment of periodontal disease, dental caries and those who are scheduled to visit a dentist during the study period. 2. Subjects who routinely use dentures, mouthpieces, or other appliances that require removal and replacement, or orthodontic appliances. 3. Subjects who have undergone or are currently undergoing treatment for dental implants in the past, or who plan to undergo treatment during the research period. 4. Subjects who are judged to be unsuitable as research subjects (subjects) based on the results of preliminary examinations, such as those showing mouth ulcers. 5. Subjects used toothpaste containing hydroxyapatite within one month prior to the pre-test. 6. Subjects who have used mouthwash within one month prior to the pre-test. 7. Subjects who used an interdental brush within 1 month prior to the pre-test. 8. Subjects who have taken antibiotics (antimicrobials) within 3 months prior to the pre-test 9. Subjects who have had a fluoride rinse or application at a dental clinic within one month prior to the pre-test, or those who plan to have a rinse or application during the research period. 10. Subjects who have had abnormalities in clinical laboratory values or cardiopulmonary function and have been judged to be unsuitable for participation in the research. 11. Subjects at risk of developing allergies related to the research. 12. Subjects with a disease requiring constant medication (whether topical or oral), those with a disease under treatment (excluding dry eye and eye strain), and those with a history of a serious disease requiring medication treatment. 13. Subjects who work in shifts or late at night and have an irregular rhythm of life. 14. Subjects in other clinical studies, clinical trials, or human trials within one month prior to the start of this research.

Design outcomes

Primary

MeasureTime frame
Oral bacterial index

Secondary

MeasureTime frame
Oral bacterial flora Caries count, Salivary acidity, Buffering capacity of saliva, White blood cell count, Protein level, Ammonia concentration

Countries

Japan

Contacts

Public ContactYoshimi Bansho

EP Mediate Co., Ltd. R&D Support Center Foods Department Section 1

bansho.yoshimi189@eps.co.jp070-3023-8209

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026