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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035639
Receipt No. 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

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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)
Email 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
Email stjc@ngt.ndu.ac.jp

Sponsor
Institute The Nippon Dental University College at Niigata
Institute
Department

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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040596

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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