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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037940
Receipt No. R000043245
Scientific Title Examination of effectiveness of combination therapy of periodontal tissue regeneration drug, Regroth, and carbonate apatite, Cytrans Granules, for periodontal tissue regenaration
Date of disclosure of the study information 2020/01/01
Last modified on 2020/09/05

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Basic information
Public title Examination of effectiveness of combination therapy of periodontal tissue regeneration drug, Regroth, and carbonate apatite, Cytrans Granules, for periodontal tissue regenaration
Acronym Study on combination therapy of Regroth and Cytrans Granules for periodontal tissue regeneration
Scientific Title Examination of effectiveness of combination therapy of periodontal tissue regeneration drug, Regroth, and carbonate apatite, Cytrans Granules, for periodontal tissue regenaration
Scientific Title:Acronym Study on combination therapy of Regroth and Cytrans Granules for periodontal tissue regeneration
Region
Japan

Condition
Condition Periodontal Disease
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examination on the effectiveness of combination therapy of Regroth and Cytrans Granules for regeneration of periodontal tissue destruction by periodontitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Increase in new alveolar bone at 9 months after periodontal surgery
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Combination therapy of Regroth and Cytrans Granules at periodontal surgical treatment
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Periodontal pocket depth of 4 mm or more, and vertical bone defect of 3 mm or more
Key exclusion criteria Patients with severe systemic disease
Patients who may be pregnant or pregnant
Patients with mental illness
Patients with hypersensitivity to "Regroth" or "Cytrans Granules"
Patients with malignant tumor in oral cavity or patients with its history
Case of predicted not to able to complete closure of wound surface when filling with Cytrans Granules
Tooth for severe periodontal disease and tooth extraction adapted tooth
Target sample size 40

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
Email 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
Email yumoto@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

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 088-633-9294
Email 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 01 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 Open public recruiting
Date of protocol fixation
2019 Year 10 Month 31 Day
Date of IRB
2019 Year 10 Month 28 Day
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2023 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
2019 Year 09 Month 05 Day
Last modified on
2020 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043245

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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