UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035639 |
|---|---|
| Receipt number | R000040596 |
| Scientific Title | Observation of intravital lingual surface features and distributed lingual papillae of adult healthy subjects for development of the oral mucosa examinational apparatus. |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2019/03/11 13:27:50 |
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Basic information
Public title
Observation of intravital lingual surface features and distributed lingual papillae of adult healthy subjects for development of the oral mucosa examinational apparatus.
Acronym
Observation of intravital lingual papillae of adult healthy subjects for development of examinational apparatus.
Scientific Title
Observation of intravital lingual surface features and distributed lingual papillae of adult healthy subjects for development of the oral mucosa examinational apparatus.
Scientific Title:Acronym
Observation of intravital lingual papillae of adult healthy subjects for development of examinational apparatus.
Region
| Japan |
Condition
Condition
Lingual mucosa on the healthy subjects
Classification by specialty
| Oral surgery | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For development of the oral mucosa examinational apparatus, we observe intravital lingual surface features and distributed lingual papillae of adult healthy subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Image observation
2)Morphometry of lingual papillae
3)Assessment of tongue-coat
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
| 19 | years-old | <= |
Age-upper limit
| 23 | years-old | >= |
Gender
Female
Key inclusion criteria
Assenter of informed consent
Healthy (According to Pre-survey Questionnaire)
Key exclusion criteria
Lacked adequate amount of mouth opening for observation
Obstacles (e.g. vomiting reflex) for observation
Smoking habits
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Yoshimura DDS., PhD |
Organization
Faculty of Life Dentistry, The Nippon Dental University at Niigata
Division name
Department of Anatomy
Zip code
Address
1-8 Hamaura-cho Chuo-ku Niigata City., Niigata. 951-8580
TEL
0252671500(2487)
yoshimura@ngt.ndu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ms. Satoko Tsuchida |
Organization
The Nippon Dental University College at Niigata
Division name
Department of Dental Hygiene
Zip code
Address
1-8 Hamaura-cho Chuo-ku Niigata City., Niigata. 951-8580
TEL
0252118163
Homepage URL
stjc@ngt.ndu.ac.jp
Sponsor or person
Institute
The Nippon Dental University College at Niigata
Institute
Department
Personal name
Funding Source
Organization
The Nippon Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
日本歯科大学新潟短期大学(新潟県)/The Nippon Dental University College at Niigata(Niigata Prefecture)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 27 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 18 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 07 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Observational Study (Non-intervention study)
Cross-sectional Study
Non-Cohort study
Non-Case-Control study
Management information
Registered date
| 2019 | Year | 01 | Month | 23 | Day |
Last modified on
| 2019 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040596
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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