UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035282 |
|---|---|
| Receipt number | R000040197 |
| Scientific Title | A pilot study on the effects of food on oral functions |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2020/06/24 16:51:08 |
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Basic information
Public title
A pilot study on the effects of food on oral functions
Acronym
A pilot study on the effects of food on oral functions
Scientific Title
A pilot study on the effects of food on oral functions
Scientific Title:Acronym
A pilot study on the effects of food on oral functions
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of food on oral functions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of oral function (oral hypofunction)
Assessment of dental hard tissue (anti-dental caries)
Assessment of oral hygiene (saliva volume, plaque volume, oral microbiome)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of tablet containing no functional materials 3 times a day for 2 weeks
Interventions/Control_2
Ingestion of tablet containing functional materials 3 times a day for 2 weeks
Interventions/Control_3
Ingestion of pellet of gum containing no functional materials 3 times a day for 2 weeks
Interventions/Control_4
Ingestion of pellet of gum containing functional materials 3 times a day for 2 weeks
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key 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
Key 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
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Takii |
Organization
Ezaki Glico Co., Ltd.
Division name
Institute of health sciences
Zip code
Address
4-6-5, Utajima, Nishiyodogawa-ku, Osaka, Japan
TEL
06-6477-8425
hiroshi.takii@glico.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Takii |
Organization
Ezaki Glico Co., Ltd.
Division name
Institute of health sciences
Zip code
Address
4-6-5, Utajima, Nishiyodogawa-ku, Osaka, Japan
TEL
06-6477-8425
Homepage URL
hiroshi.takii@glico.com
Sponsor or person
Institute
Ezaki Glico Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Tokyo Medical and Dental University
Graduate School of Medical and Dental Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2018 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 17 | Day |
Last modified on
| 2020 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040197
