UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039846 |
|---|---|
| Receipt number | R000045434 |
| Scientific Title | Examination of advanced dental technology with EMDOGAIN gel in periodontal regenerative therapy |
| Date of disclosure of the study information | 2020/03/20 |
| Last modified on | 2020/03/17 12:13:10 |
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Basic information
Public title
Examination of advanced dental technology with EMDOGAIN gel in periodontal regenerative therapy
Acronym
Examination of advanced dental technology with EMDOGAIN gel in periodontal regenerative therapy
Scientific Title
Examination of advanced dental technology with EMDOGAIN gel in periodontal regenerative therapy
Scientific Title:Acronym
Examination of advanced dental technology with EMDOGAIN gel in periodontal regenerative therapy
Region
| Japan |
Condition
Condition
periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A growing amount of evidence indicates that enamel matrix protein is effective for periodontal regenerative therapy. The purpose of this study is to evaluate the clinical outcomes of the periodontal regenerative therapy using EMDOGAIN, which is gel preparation containing emanel matrix protein.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Probing pocket depth, clinical attachment level, width of keratinized gingiva and the amount of radiographical bone formation
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Periodontal regeneration therapy using EMDOGAIN is performed for subjects who are diagnosed as needing periodontal regeneration therapy.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Chronic periodontitis patients who visits Tokyo Medical and Dental University Hospital and plans to receive periodontal regenerative therapy using EMDGAIN
2. Patients who gave informed consent
3. 20 years old or more
Key exclusion criteria
1. Systemic diseases which might affect periodontitis
2. Subjects who are judged to lack the ability to give informed consent
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Mizutani |
Organization
Tokyo Medical and Dental University
Division name
Department of periodontology
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
0358035488
mizuperi@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Mizutani |
Organization
Tokyo Medical and Dental University
Division name
Department of periodontology
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
0358035488
Homepage URL
mizuperi@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
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
Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel
0358035488
mizuperi@tmd.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
東京医科歯科大学歯学部附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 20 | 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
538
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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2010 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2010 | 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 | 17 | Day |
Last modified on
| 2020 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045434
| 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 |
