UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027150
Receipt number 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 2023/05/01 09:41:40

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Nagasaki University

Institute

Department

Personal name



Funding Source

Organization

Nagasaki 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

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

Completed

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

2023 Year 05 Month 01 Day



Link to view the page

Value
https://center6.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