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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032382
Receipt No. R000036930
Scientific Title Clinical verification of mouth spray derived from derivative GGsTopTM
Date of disclosure of the study information 2018/06/01
Last modified on 2019/04/29

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Basic information
Public title Clinical verification of mouth spray derived from derivative GGsTopTM
Acronym Clinical verification of mouth spray derived from GGsTopTM
Scientific Title Clinical verification of mouth spray derived from derivative GGsTopTM
Scientific Title:Acronym Clinical verification of mouth spray derived from GGsTopTM
Region
Japan

Condition
Condition xerostomia, stomatitis, mouth wound, difficulty in swallowing caused by dry mouth
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 GGsTop, Glutathione breakdown enzyme, has antioxidant effect, inducing ability of collagen and elastin from fibroblasts. GGsTop is used for skin cosmetic to restore moisture to the skin. Dry mouth causes various type of oral disease such as periodontitis, dental caries, stomatitis, mouth wound, eating and swallowing difficulties. The aim of this study is to verify a new product of mouth spry mainly containing GGsTop for oral moisturizing and oral wound healing.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Administration after 1 month
Moisture of oral mucosa
Key secondary outcomes Administration after 1 month
Inflammatory conditions of oral mucosa
Inflammatory condition of periodontal tissue
Repetitive saliva swallowing test

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
Other
Interventions/Control_1 GGsTop administering group (1ml/Times)
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Individuals with xerostomia, stomatitis, mouth wound, difficulty in swallowing caused by dry mouth
Key exclusion criteria Pregnant woman, Infant
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yoko
Middle name
Last name Tanaka
Organization Nihon university School of Dentistry at Matsudo
Division name Spechail Needs Dentistry
Zip code 271-8587
Address 2-870-1, sakaecho-nishi, Matsudo, Chiba
TEL 047-360-9443
Email tanaka.yoko@nihon-u.ac.jp

Public contact
Name of contact person
1st name Yoko
Middle name
Last name Tanaka
Organization Nihon university School of Dentistry at Matsudo
Division name Spechail Needs Dentistry
Zip code 271-8587
Address 2-870-1, Sakaecho-nishi, Mtsudo, Chiba
TEL 047-360-9443
Homepage URL
Email tanaka.yoko@nihon-u.ac.jp

Sponsor
Institute Nihon university School of Dentistry at Matsudo
Institute
Department

Funding Source
Organization Nihon university School of Dentistry at Matsudo
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 Nihon Universtiy School of Dentistry at Matsudo
Address 2-870-1, sakaecho-nichi, matsudo, Chiba
Tel 047-360-9443
Email tanaka.yoko@nihon-u.ac.jp

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

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 05 Month 14 Day
Date of IRB
2018 Year 08 Month 22 Day
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 25 Day
Last modified on
2019 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036930

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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