UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A research of the masticatory movement on the gum chewing among dentistry patients of children
Title of the study (Brief title)	A research of the masticatory movement on the gum chewing among dentistry patients of 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 characteristic of masticatory movements of several kinds of chewing gums among dentistry patients of children
Basic objectives2	Others
Basic objectives -Others	Characteristics of masticatory movements (Measurements of masticatory path width)
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Masticatory path width
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	8 years-old <=
Age-upper limit	12 years-old >=
Gender	Male and Female
Key inclusion criteria	Children of mixed dentition (Hellman's dental age IIIB)
Key exclusion criteria	Those who is observed abnormality at periodontium or jaw joints or masticatory muscles or masticatory movement on clinical observations Those who has anterior cross-bite or dual bite Those who missed maxillary or mandibular first premolar Those who has food allergy
Target sample size	10

Research contact person
Name of lead principal investigator	Kasai Kazutaka
Organization	Nihon University School of Dentistry at Matsudo
Division name	Department of Orthodontics
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	Negishi Shinichi
Organization	Nihon University School of Dentistry at Matsudo
Division name	Department of Orthodontics
Address	2-870-1, Sakaecho-Nishi, Matsudo, Chiba
TEL	047-360-9410
Homepage URL
Email	negishi.shinichi@gmail.com

Sponsor
Institute	Nihon University School of Dentistry at Matsudo
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	LOTTE CO.,LTD
Name of secondary funｄer(s)

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	日本大学松戸歯学部付属病院　Nihon University School of Dentistry Dental Hospital

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 21 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 05 Month 29 Day
Anticipated trial start date	2017 Year 06 Month 22 Day
Last follow-up date	2018 Year 04 Month 09 Day
Date of closure to data entry	2018 Year 04 Month 09 Day
Date trial data considered complete	2018 Year 04 Month 09 Day
Date analysis concluded	2018 Year 05 Month 02 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Ask the children to chew the 4 different gums independently and measure the each masticatory path width and compare the characteristic of the masticatory movements. All the subjects recruited in this test are children who visit to Nihon University School of Dentistry Dental Hospital from June-August in 2017 and meet the required standards.

Management information
Registered date	2017 Year 06 Month 20 Day
Last modified on	2018 Year 07 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031877