UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038195 |
|---|---|
| Receipt number | R000043375 |
| Scientific Title | SP1458 |
| Date of disclosure of the study information | 2019/10/03 |
| Last modified on | 2019/10/03 17:16:05 |
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Basic information
Public title
Study on Oral Environment Improvement Effect of Continuous Ingestion of Masticable Foods
Acronym
Study on Masticable Food for Improvement of Oral Environment
Scientific Title
SP1458
Scientific Title:Acronym
SP1458
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess changes in the oral environment in men and women aged 20 to 65 years with inadequate oral care who were randomly assigned to receive either ingredient-containing foods or ingredient-free foods for 6 weeks
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bleeding on Probing
Key secondary outcomes
PPD
CAL
P1I
GI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Masticable foods containing ingredients
Interventions/Control_2
Masticable foods without ingredients
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects who gave written informed consent to participate in the study.
2) Individuals who are diagnosed as having no health problems based on a physician's interview
3) Men and women aged 20-65 years at the time of informed consent
4) Non-smokers for at least 1 year
5) Persons who have not undergone dental treatment or cleaning by a dentist within 6 months retrospectively from the date of the screening examination.
7) Those who have 24 or more teeth left behind.
Key exclusion criteria
1) Pregnant women or women of childbearing potential, and women who wish to become pregnant during the study period
2) Lactating women
3) Persons with a history of serious disease (including Sjoegren's syndrome)
4) Patients with a history of hypersensitivity to gelatin or sugar alcohol
5) Persons who may require dental treatment (including orthodontic treatment) during the study participation period.
6) Extraction of wisdom teeth or treatment of tooth extraction other than tooth extraction for convenience in orthodontic treatment
7) Patients who have taken antibiotics (antibiotics/antibiotics) within 3 months
8) Persons who may use antihistamines (e.g., due to pollinosis or allergy) during the study period (survey the use of antihistamines and cold remedies in advance questionnaires or diaries).
9) Other persons who the investigator or the investigator judges to be inappropriate as subjects of the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Saito |
Organization
Otsuka Pharmaceutical,Co.,Ltd.
Division name
Otsu Nutraceuticals Research Institute
Zip code
520-0002
Address
3-31-13, Saikawa, Otsu-shi, Shiga 520-0002, Japan
TEL
077-521-8835
Saito.Hiroshi@otsuka.jp
Public contact
Name of contact person
| 1st name | Satomi |
| Middle name | |
| Last name | Nakano |
Organization
Medical Corporation Chiseikai Tokyo Center Clinic
Division name
Clinical Research Center
Zip code
1030028
Address
KT Bldg, 2F, 1-1-8 Taesu, Chuo-ku, Tokyo 103-0028, JAPAN
TEL
070-3351-3779
Homepage URL
nakano_satomi@tc-clinic.jp
Sponsor or person
Institute
Medical Corporation Chiseikai Tokyo Center Clinic
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical,Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Conference of Clinical Research
Address
Ikebukuro YS Bldg. 8F, 1-13-23 Minami-ikebukuro, Toshima-ku, Tokyo 171-0022,Japan
Tel
03-6868-7022
nakagawa-kengo@3hcts.co.jp
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
| 2019 | Year | 10 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 03 | Day |
Last modified on
| 2019 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043375
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
