UMIN-CTR Clinical Trial

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	Main results already published
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	2021 Year 06 Month 28 Day

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