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Recruitment status Completed
Unique ID issued by UMIN UMIN000014687
Receipt No. R000017000
Scientific Title The effect of a mouthpiece made by EVA sheet for night guard on oral mucosal disease including angular stomatitis
Date of disclosure of the study information 2014/07/28
Last modified on 2018/07/31

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Basic information
Public title The effect of a mouthpiece made by EVA sheet for night guard on oral mucosal disease including angular stomatitis
Acronym The effect of EVA night guard on oral mucosal disease
Scientific Title The effect of a mouthpiece made by EVA sheet for night guard on oral mucosal disease including angular stomatitis
Scientific Title:Acronym The effect of EVA night guard on oral mucosal disease
Region
Japan

Condition
Condition Oral mucosal disease
Classification by specialty
Dermatology Oral surgery Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate whether EVA night guard can suppress the development of oral mucosal disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Duration, site and size of oral mucosal disease
Key secondary outcomes The alteration of antioxidant, reactive oxygen, inflammatory cytokine and interleukin by saliva test

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 mouthpiece
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Outpatients who have oral mucosal disease including angular stomatitis
Key exclusion criteria 1. Those who are taking medication suspected to be those that can affect test results.
2. Those who have taken daily health foods appear to have the potential to affect the test results.
3. Those who suspected of being pregnant or during pregnancy, and those who are breastfeeding.
4. Those who have ingested too much alcohol.
5. Those who would have an allergic symptom by EVA sheet.
6. Those who are participating in other clinical trials.
7. Persons with pre-existing severe liver damage, kidney failure, heart disease.
8. Persons with history of past and present hepatitis.
9. Those who has severe anemia
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naozumi Ishimaru
Organization The University of Tokushima, Graduate School
Division name Department of Oral Molecular Pathology, Institute of Health Biosciences
Zip code
Address 3-18-15 Kuramoto, Tokushima
TEL 088-633-7328
Email ishimaru.n@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidesuke Tada
Organization The University of Tokushima, Graduate School
Division name Department of Oral Molecular Pathology, Institute of Health Biosciences
Zip code
Address 3-18-15 Kuramoto, Tokushima
TEL 088-633-7328
Homepage URL
Email hidebupq333@gmail.com

Sponsor
Institute The University of Tokushima
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization The University of Tokushima
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 徳島大学病院(徳島県)、医療法人社団多田歯科医院(兵庫県)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5839199/
Number of participants that the trial has enrolled
Results
Mouthguard use may be beneficial for preventing RAS development.
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
2014 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 28 Day
Last modified on
2018 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017000


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