UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036173 |
|---|---|
| Receipt number | R000041211 |
| Scientific Title | A research of oral function improvement by training with chewing gum in children |
| Date of disclosure of the study information | 2019/03/13 |
| Last modified on | 2021/03/13 11:47:19 |
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Basic information
Public title
A research of oral function improvement by training with chewing gum in children
Acronym
A research of oral function improvement by training with chewing gum in children
Scientific Title
A research of oral function improvement by training with chewing gum in children
Scientific Title:Acronym
A research of oral function improvement by training with chewing gum in children
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To research the effect of training with chewing gums to oral function in children
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Masticatory movement: masticatory path width
Key secondary outcomes
1) masticatory movement: the number of chewing and the angle of masticatory path
2) dental model : dental arch width, dental arch length, the capacity of palate
3) intraoral and facial photography: molar relation and facial index
4) oral function: bite force, lip pressure and the tongue pressure
5) sound: formant
6) breathing: respiratory rate, oxygen saturation, nasal resistance, tidal volume, SpO2, EtCO2
7) questionnaire
8) the number of S.mutans in the saliva
1.the number of Streptococcus
2.the number of S.mutans (S.sobrinus is included.)
3.the ratio of number of S.mutans to Streptococcus
4.the number of Lactobacillus
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
training with chewing gums for 3 months
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
| 10 | years-old | <= |
Age-upper limit
| 11 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
5th grader of Kogasaki elementary school at Matsudo in 2019
Key exclusion criteria
Those who are attached orthodontic appliance.
Those who have too severe vomit reflection to take dental impression.
Those who have deciduous tooth very likely to be shed by taking dental impression.
Target sample size
133
Research contact person
Name of lead principal investigator
| 1st name | Kazutaka |
| Middle name | |
| Last name | Kasai |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of Orthodontics
Zip code
271-0061
Address
2-870-1, Sakaecho-Nishi, Matsudo, Chiba
TEL
047-360-9410
kasai.kazutaka@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Ishii |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of Orthodontics
Zip code
271-0061
Address
2-870-1, Sakaecho-Nishi, Matsudo, Chiba
TEL
047-360-9412
Homepage URL
ishii.kaori@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Dentistry at Matsudo
Institute
Department
Personal name
Funding Source
Organization
LOTTE CO.,Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
LOTTE CO.,Ltd
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board in Nihon University School of Dentistry at Matsudo
Address
2-870-1, Sakaecho-Nishi, Matsudo, Chiba
Tel
047-368-6111
kj.md.ml@nihon-u.ac.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
松戸市立古ケ崎小学校（千葉県）/Kogasaki elementary school at Matsudo
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 13 | 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 | 18 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | 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 | 03 | Month | 12 | Day |
Last modified on
| 2021 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041211
