UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027748 |
|---|---|
| Receipt number | R000031788 |
| Scientific Title | Aesthetic improvement of tooth root exposure using collagen graft |
| Date of disclosure of the study information | 2017/06/14 |
| Last modified on | 2022/06/20 19:13:15 |
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Basic information
Public title
Aesthetic improvement of tooth root exposure using collagen graft
Acronym
Aesthetic improvement of tooth root exposure using collagen graft
Scientific Title
Aesthetic improvement of tooth root exposure using collagen graft
Scientific Title:Acronym
Aesthetic improvement of tooth root exposure using collagen graft
Region
| Japan |
Condition
Condition
Gingival Recession
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of root surface coating method with artificial membrane
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gingival margin level, color tone, degree of absorption in the living body after 2 weeks, 1, 3, 6 months, 1 year
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Number of interventions: 1 time
Follow-up period after surgery 1 year
Drug usage: Approximately 2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Gingival retraction of 4 mm or more
Class I or II in Miller's classification
CEJ is clear
There is no caries
There is no substantial defect
smoker
Afflicted person
Non-adaptation to periodontal surgery
I have periodontal disease
I have had periodontal treatment in the past 2 years
There is plaque adhesion, bleeding
There is a substantial deficit
Key exclusion criteria
smoker
Afflicted person
Non-adaptation to periodontal surgery
I have periodontal disease
I have had periodontal treatment in the past 2 years
There is plaque adhesion, bleeding
There is a substantial deficit
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiko Asano |
Organization
School of Dentistry,Iwate Medical University
Division name
Division for Operative Dentistry and Endodontics Department of Conservative Dentistry
Zip code
Address
1-3-27 Chuoudori Morioka Japan
TEL
019-651-5111
akiasano@iwate-med.ac.j
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Asano |
Organization
School of Dentistry,Iwate Medical University
Division name
Division for Operative Dentistry and Endodontics Department of Conservative Dentistry
Zip code
Address
1-3-27 Chuoudori Morioka Japan
TEL
019-651-5111
Homepage URL
akiasano@iwate-med.ac.jp
Sponsor or person
Institute
School of Dentistry,Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Dentium
Organization
Division
Category of Funding Organization
Outside Japan
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
| 2017 | Year | 06 | Month | 14 | 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
| 2017 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2018 | 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
| 2017 | Year | 06 | Month | 14 | Day |
Last modified on
| 2022 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031788
