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A pilot study on the effects of food on oral functions

A pilot study on the effects of food on oral functions - A pilot study on the effects of food on oral functions

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000035282
Enrollment
120
Registered
2020-04-01
Start date
2018-12-17
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

Healthy adults

Interventions

Ingestion of tablet containing no functional materials 3 times a day for 2 weeks Ingestion of tablet containing functional materials 3 times a day for 2 weeks Ingestion of pellet of gum containing no

Sponsors

Ezaki Glico Co., Ltd.
Lead Sponsor
Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Those regularly taking three meals 2) Those who can measure four or more teeth on the labial side and buccal side of 6 teeth of 16 (maxillary right first molar, FDI tooth code; same below), 21 (maxillary left medial tooth), 24 (maxillary left first bicuspid), 36 (mandibular left first molar), 41 (mandibular right middle incisor) and 44 (mandible right first bicuspid) Those who have FDI codes 17, 15, 11, 22, 25, 37, 35, 31, 42, 45 as substitutes for the six representative teeth 3) Those who do not have severe periodontal disease 4) Currently, those who are not treated for dental caries and periodontal disease, and with 20 or more teeth 5) Those who can not take foods or supplements written with oral hygiene, such as antimicrobial-containing tablets, Lactobacillus-containing foods and xylitol-containing gums during the test period 6) Those who can be set the oral device 7) Those who have no history of eating disorder or trismus 8) Those who do not regularly use antibiotics 9) Those who are not pregnant or lactating 10) Those who are not alcohol mass drinker or not dependent 11) Those who are not smokers 12) Those who are allowed to prohibit the use of toothpaste, mouthwash, floss and tongue brush with antibiotic and fungicide during the test period 13) Those who are allowed to use designated toothbrush and toothpaste during the test period 14) Those who received sufficient explanation about the purpose and contents of the exam, have a capacity for agreement, apply for participation voluntarily and are agree to participate in this study in writing

Exclusion criteria

Exclusion criteria: 1) Those who have dental caries (C 3 or more) or severe periodontal disease at the screening test 2) Those who is taking medication for suffering from diabetes, chronic kidney disease, gastrointestinal disorder, lung disease, malignant tumor, autoimmune disease, etc. 3) Those who are undergoing treatment for serious diseases or who need to be implemented during the test period 4) Those who are or intend to currently participate in other medicines or food examination etc. 5) Those with stimulated saliva volume of less than 3.0 ml for 5 minutes 6) Those who has food allergy 7) Those wearing removable denture 8) Those who is during pregnancy, who intend to become pregnant during the study period or are breast-feeding 9) When you take antibiotics or disinfectant during the test (depending on its frequency and level) 10) When you ingest the oral health care product during the test (depending on its frequency and level) 11) Those who judged that examination is inappropriate by study responsible person 12) Those who can not be refrained from excessive intake of living bacteria-containing foods such as Lactobacillus and bifidobacteria, other fermented foods (natto, kimchi, etc.) during the test period 13) Those who are suffering from a disease requiring urgent treatment, or who have serious complications 14) Those who need dental checkup or treatment / surgery related to oral disease during the test period 15) Those who are judged unsuitable as a research subject from the respondents of the research subject background questionnaire

Design outcomes

Primary

MeasureTime frame
Assessment of oral function (oral hypofunction) Assessment of dental hard tissue (anti-dental caries) Assessment of oral hygiene (saliva volume, plaque volume, oral microbiome)

Countries

Japan

Contacts

Public ContactHiroshi Takii

Ezaki Glico Co., Ltd. Institute of health sciences

hiroshi.takii@glico.com06-6477-8425

Outcome results

None listed

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