UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041211