UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027831 |
|---|---|
| Receipt number | 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 15:51:05 |
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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
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
negishi.shinichi@gmail.com
Sponsor or person
Institute
Nihon University School of Dentistry at Matsudo
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
