UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032382 |
|---|---|
| Receipt number | 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 | 2021/06/28 19:07:36 |
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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
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
tanaka.yoko@nihon-u.ac.jp
Sponsor or person
Institute
Nihon university School of Dentistry at Matsudo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036930
