UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037940
Receipt number R000043245
Scientific Title Examination of effectiveness of combination therapy of periodontal tissue regeneration drug, Regroth, and carbonate apatite, Cytrans Granules, for periodontal tissue regenaration
Date of disclosure of the study information 2020/01/01
Last modified on 2023/09/08 20:42:42

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Basic information

Public title

Examination of effectiveness of combination therapy of periodontal tissue regeneration drug, Regroth, and carbonate apatite, Cytrans Granules, for periodontal tissue regenaration

Acronym

Study on combination therapy of Regroth and Cytrans Granules for periodontal tissue regeneration

Scientific Title

Examination of effectiveness of combination therapy of periodontal tissue regeneration drug, Regroth, and carbonate apatite, Cytrans Granules, for periodontal tissue regenaration

Scientific Title:Acronym

Study on combination therapy of Regroth and Cytrans Granules for periodontal tissue regeneration

Region

Japan


Condition

Condition

Periodontal Disease

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examination on the effectiveness of combination therapy of Regroth and Cytrans Granules for regeneration of periodontal tissue destruction by periodontitis

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Increase in new alveolar bone at 9 months after periodontal surgery

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

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Combination therapy of Regroth and Cytrans Granules at periodontal surgical treatment

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

Periodontal pocket depth of 4 mm or more, and vertical bone defect of 3 mm or more

Key exclusion criteria

Patients with severe systemic disease
Patients who may be pregnant or pregnant
Patients with mental illness
Patients with hypersensitivity to "Regroth" or "Cytrans Granules"
Patients with malignant tumor in oral cavity or patients with its history
Case of predicted not to able to complete closure of wound surface when filling with Cytrans Granules
Tooth for severe periodontal disease and tooth extraction adapted tooth

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Hiromichi
Middle name
Last name Yumoto

Organization

Tokushima University Graduate School

Division name

Department of Periodontology and Endodontology

Zip code

770-8504

Address

3-18-15 Kuramoto-cho, Tokushima, Tokushima

TEL

0886337343

Email

yumoto@tokushima-u.ac.jp


Public contact

Name of contact person

1st name Hiromichi
Middle name
Last name Yumoto

Organization

Tokushima University Graduate School

Division name

Department of Periodontology and Endodontology

Zip code

770-8504

Address

3-18-15 Kuramoto-cho, Tokushima, Tokushima

TEL

0886337343

Homepage URL


Email

yumoto@tokushima-u.ac.jp


Sponsor or person

Institute

Tokushima University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokushima University Hospital, Clinical Trial Center for Developmental Therapeutics

Address

2-50-1 Kuramoto-cho, Tokushima, Tokushima

Tel

088-633-9294

Email

awachiken@tokushima-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

2020 Year 01 Month 01 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

2019 Year 10 Month 31 Day

Date of IRB

2019 Year 10 Month 28 Day

Anticipated trial start date

2019 Year 11 Month 01 Day

Last follow-up date

2026 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

2019 Year 09 Month 05 Day

Last modified on

2023 Year 09 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043245


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name