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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027831
Receipt No. R000031877
Scientific Title A research of the masticatory movement on the gum chewing among dentistry patients of children
Date of disclosure of the study information 2017/06/21
Last modified on 2018/07/02

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Basic information
Public title A research of the masticatory movement on the gum chewing among dentistry patients of children
Acronym A research of the masticatory movement on the gum chewing among dentistry patients of children
Scientific Title A research of the masticatory movement on the gum chewing among dentistry patients of children
Scientific Title:Acronym 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
1st name
Middle name
Last name Kasai Kazutaka
Organization Nihon University School of Dentistry at Matsudo
Division name Department of Orthodontics
Zip code
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
Middle name
Last name Negishi Shinichi
Organization Nihon University School of Dentistry at Matsudo
Division name Department of Orthodontics
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2017 Year 05 Month 29 Day
Date of IRB
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

Other
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

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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