UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039756 |
|---|---|
| Receipt number | R000044942 |
| Scientific Title | Effect of G U m Medical Paste EX on gingival inflammation improvement |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2023/09/12 15:13:51 |
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Basic information
Public title
Verification of the effect of G U m Medical Paste EX on the improvement of gingival inflammation and comparison with different application methods
-Pilot research-
Acronym
Verification of the effect of G U m Medical Paste EX on the improvement of gingival inflammation and comparison with different application methods
Scientific Title
Effect of G U m Medical Paste EX on gingival inflammation improvement
Scientific Title:Acronym
Effect of G U m Medical Paste EX on gingival inflammation improvement
Region
| Japan |
Condition
Condition
Chronic Periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of G U m Medical Paste EX for stabilizing and improving the condition of chronic periodontal disease and the effect of different application methods
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in bacterial counts and inflammatory marker levels
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Placebo group
Interventions/Control_2
Toothbrush application group
Interventions/Control_3
Toothbrush application group
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients during Maintenance or SPT of chronic periodontitis
Key exclusion criteria
Pregnant or during lactation
Those who have allergic symptoms to any of the active ingredients
Taking anticoagulants or prone to bleeding
During cancer treatment
Those who have received organ transplants in the past
Those who have taken drugs such as antibacterial drugs and anti-inflammatory drugs within the past month
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiromichi |
| Middle name | |
| Last name | Yumoto |
Organization
Tokushima University Graduate School
Division name
Department of Periodontology and Endodontology
Zip code
770-8504
Address
3-18-15 Kuramoto-cho, Tokushima, Tokushima
TEL
0886337343
yumoto@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromichi |
| Middle name | |
| Last name | Yumoto |
Organization
Tokushima University Graduate School
Division name
Department of Periodontology and Endodontology
Zip code
770-8504
Address
3-18-15 Kuramoto-cho, Tokushima, Tokushima
TEL
0886337343
Homepage URL
yumoto@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushima University Hospital, Clinical Trial Center for Developmental Therapeutics
Address
2-50-1 Kuramoto-cho, Tokushima, Tokushima
Tel
088633-9294
awachiken@tokushima-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
| 2020 | Year | 04 | 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
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2020 | Year | 03 | Month | 10 | Day |
Last modified on
| 2023 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044942
