UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034480 |
|---|---|
| Receipt number | R000039319 |
| Scientific Title | Examination of effectiveness of combination therapy of periodontal tissue regeneration drug Regroth and bone substitute material for periodontal tissue regeneration |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2018/10/13 21:03:30 |
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Basic information
Public title
Examination of effectiveness of combination therapy of periodontal tissue regeneration drug Regroth and bone substitute material for periodontal tissue regeneration
Acronym
Study on combination therapy of Regroth and bone substitute material for periodontal tissue regeneration
Scientific Title
Examination of effectiveness of combination therapy of periodontal tissue regeneration drug Regroth and bone substitute material for periodontal tissue regeneration
Scientific Title:Acronym
Study on combination therapy of Regroth and bone substitute material 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 bone substitute material 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
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Application of Regroth only at periodontal surgical treatment
Interventions/Control_2
Combination therapy of Regroth and bone substitute material at periodontal surgical treatment
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"
Patient with malignant tumor in oral cavity or patient with an its history
Case of predicted not to able to complete closure of the wound surface when filling with substitute bone material
Tooth for severe periodontal disease and tooth extraction adapted tooth
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromichi Yumoto |
Organization
Tokushima University Graduate School
Division name
Department of Periodontology and Endodontology
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima, Tokushima
TEL
088-633-7343
yumoto@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromichi Yumoto |
Organization
Tokushima University Graduate School
Division name
Department of Periodontology and Endodontology
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima, Tokushima
TEL
088-633-7343
Homepage URL
yumoto@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokushima University Hospital
Department of Periodontology and Endodontology
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
Address
Tel
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 | 12 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 13 | Day |
Last modified on
| 2018 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039319
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
