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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027748
Receipt No. 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 2017/06/14

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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
Email 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
Email akiasano@iwate-med.ac.jp

Sponsor
Institute School of Dentistry,Iwate Medical University
Institute
Department

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
Email

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 No longer recruiting
Date of protocol fixation
2017 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 15 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
2017 Year 06 Month 14 Day
Last modified on
2017 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031788

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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