UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041765 |
|---|---|
| Receipt number | R000047513 |
| Scientific Title | The measurement of connective tissue graft volume using the optical impression |
| Date of disclosure of the study information | 2020/09/11 |
| Last modified on | 2021/03/15 09:12:34 |
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Basic information
Public title
The measurement of connective tissue graft volume using the optical impression
Acronym
The measurement of connective tissue graft volume
Scientific Title
The measurement of connective tissue graft volume using the optical impression
Scientific Title:Acronym
The measurement of connective tissue graft volume
Region
| Japan |
Condition
Condition
Gingival recession
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the contraction rate of the connective tissue graft with an intraoral scanner and study the optimal size of the connective tissue graft.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in gingival recession and the amount of graft contraction after connective tissue graft.
Key secondary outcomes
Probing pocket depth, clinical attachment level, bleeding on probing, tooth mobility, gingival recession depth, gingival recession width, gingival index, plaque index.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
The person with gingival recession.
Key exclusion criteria
The person with systemic infectious disease.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Takeda |
Organization
Tokyo Medical and Dental University
Division name
Department of Periodontology
Zip code
113-8510
Address
1-5-45 Yushima Bunkyo-ku Tokyo Japan
TEL
03-5803-5488
tak2peri@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Takeda |
Organization
Tokyo Medical and Dental University
Division name
Department of Periodontology
Zip code
113-8510
Address
1-5-45 Yushima Bunkyo-ku Tokyo Japan
TEL
03-5803-5488
Homepage URL
tak2peri@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
Japan
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
03-5803-5488
tak2peri@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（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 11 | 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
| 2020 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Further detailed analysis will be conducted in the future.
Management information
Registered date
| 2020 | Year | 09 | Month | 11 | Day |
Last modified on
| 2021 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047513
| 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 |
