UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047857 |
|---|---|
| Receipt number | R000054554 |
| Scientific Title | Project to improve chewing power using bitescan and gum |
| Date of disclosure of the study information | 2022/05/25 |
| Last modified on | 2023/05/30 09:51:26 |
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Basic information
Public title
Project to improve chewing power using bitescan and gum
Acronym
Project to improve chewing power using bitescan and gum
Scientific Title
Project to improve chewing power using bitescan and gum
Scientific Title:Acronym
Project to improve chewing power using bitescan and gum
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of whether chewing ability can be improved by sharing chewing within a family unit.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Physical and oral findings
*Age, sex
*Weight, height
*Intraoral examination
Chewing frequency measurement by bitescan
*Chewing gum
*Crunchy biscuit
*Dinner
Measurement of oral function
*Chewing ability
*Tongue and lip motor function
* salivary secretion volume during masticatory stimulation
*Bite force
Questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Consume 2 pieces of gum 3 times a day equally on both sides (at least 10 minutes per time) for 4 weeks.
The whole family wears bitescan (multiple connection model: BH-BS1RB) at dinner time to measure chewing time, number of chews, and number of chews per mouthful. Measurements will be taken about 3-4 times a week, and 15 measurements will be taken.
Interventions/Control_2
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Families that have the custom of eating dinner together
(2) Those with normal occlusion with no abnormal findings in the morphology and function of the oral and maxillofacial system.
(3) Those who have received sufficient explanation of the purpose and content of the study, have the ability to consent, have voluntarily volunteered to participate with a good understanding, and have agreed to participate in this study in writing.
Key exclusion criteria
(1) Those who suffer from diseases affecting salivary secretion
(2) Those who have symptoms that may affect intake test foods
(3) Those who take any disease or medication that is believed to have the potential to affect the results
(4) Those who may develop allergies related to the study
(5) Those who are judged by the study director to be inappropriate to participate in this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Kanno |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory, Kamukoto Research Department
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
kanno_susumu@lotte.co.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Osawa |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory, Kamukoto Research Department
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
Homepage URL
oosawa_kenji@lotte.co.jp
Sponsor or person
Institute
Lotte Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Lotte Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Niigata University
Kyushu University
SHARP CORPORATION
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1590
jimukyoku@mail.souken-r.com
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
| 2022 | Year | 05 | Month | 25 | 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
48
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
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 12 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 15 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 18 | Day |
Date analysis concluded
| 2023 | Year | 01 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 25 | Day |
Last modified on
| 2023 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054554
