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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027150
Receipt No. R000031108
Scientific Title Keratinized gingival tissue regeneration with micronized-gingival connective tissues: Pilot Study
Date of disclosure of the study information 2017/04/26
Last modified on 2019/11/11

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Basic information
Public title Keratinized gingival tissue regeneration with micronized-gingival connective tissues: Pilot Study
Acronym Keratinized tissue reconstruction with gingival micro-grat.
Scientific Title Keratinized gingival tissue regeneration with micronized-gingival connective tissues: Pilot Study
Scientific Title:Acronym Keratinized tissue reconstruction with gingival micro-grat.
Region
Japan

Condition
Condition Defect of keratinized gingiva surrounding dental impplants
Classification by specialty
Oral surgery Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to develop a new strategy of applying micro-grafts of gingival connective tissue for reconstructing or augmenting the keratinized mucosa as an alternative to the free gingival graft (FGG) or connective tissue graft (CTG).
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Safety (including the adverse event)
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
Device,equipment
Interventions/Control_1 Intervention period: 4 weeks
Intervention volume: 3x3x3mm size of gingival connective tissue: one or two pieces
Number of times of Intervention: 1 time
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Patients who received the dental implant treatment.
1. Patients who recognize the keratinized gingival defect or insufficient thickness (<2mm).
2. Patients who received the oral health care and maintain the good condition of Plaque Control.
3. The age of the patients: 20- to 75-years old
Key exclusion criteria 1. All patients are required to be nonsmokers.
2. Patients who have systemic disease, malignances, chronic infections, immune system abnormalities, septicemia, syphilis, HBV, HCV, HTLV-1, HIV, pregnancy, dementia.
3. Patients who have disorder of blood coagulation.
4. Patients who have hepatitis function disorders, metabolic bone disease or skeletal dysplasia.
5. Patients who needs the legal representative.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Izumi
Middle name
Last name Asahina
Organization Nagasaki University Graduate School of Biomediacal Sciences
Division name Department of Regenerative Oral Surgely
Zip code 852-8588
Address 1-7-1 Sakamoto, Nagasaki, 852-8588, Japan
TEL 095-819-7704
Email asahina@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Yoshinori
Middle name
Last name Sumita
Organization Faculty of Dentistry, Nagasaki University
Division name Basic and Translational Research Center for Hard Tissue Disease
Zip code 852-8588
Address 1-7-1 Sakamoto, Nagasaki, 852-8588, Japan
TEL 095-819-7706
Homepage URL
Email y-sumita@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Nagasaki 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 The Clinical Research Review Board in Nagasaki University
Address 1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-Ken
Tel 095-819-7905
Email gaibushikin@ml.nagasaki-u.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

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 26 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 Enrolling by invitation
Date of protocol fixation
2017 Year 02 Month 28 Day
Date of IRB
2019 Year 03 Month 14 Day
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
2020 Year 07 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 04 Month 26 Day
Last modified on
2019 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031108

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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