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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036173
Receipt No. 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 2019/03/12

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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
Email 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
Email ishii.kaori@nihon-u.ac.jp

Sponsor
Institute Nihon University School of Dentistry at Matsudo
Institute
Department

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
Email 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 Preinitiation
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
2019 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041211

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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