UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011709
Receipt number R000013691
Scientific Title Effects of collagen membrane for combination therapies with regenerative materials of enamel matrix derivative and xenogeneic bone graft for periodontal surgery.
Date of disclosure of the study information 2013/09/11
Last modified on 2023/09/19 11:51:48

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Basic information

Public title

Effects of collagen membrane for combination therapies with regenerative materials of enamel matrix derivative and xenogeneic bone graft for periodontal surgery.

Acronym

Combination therapies with EMD, xenogeneic bone and collagen membrane.

Scientific Title

Effects of collagen membrane for combination therapies with regenerative materials of enamel matrix derivative and xenogeneic bone graft for periodontal surgery.

Scientific Title:Acronym

Combination therapies with EMD, xenogeneic bone and collagen membrane.

Region

Japan


Condition

Condition

Periodontitis

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluate the effects of collagen membrane for combination therapies with regenerative materials of enamel matrix derivative and xenogeneic bone graft for periodontal surgery.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1) bone level
2) clinical attachment level

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

In periodontal tissue regeneration procedure, after the root surface debridement, Enamel Matrix Derivative is applied on the root surface and deproteinized bovine bone matrix is filled in bone defect. Then, collagen membrane is placed to cover them and sutured.

Interventions/Control_2

In periodontal tissue regeneration procedure, after the root surface debridement enamel matrix derivative is applied on the root surface and deproteinized bovine bone matrix was filled in bone defect. And the wound was sutured.

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

30 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with periodontitis accompanied with proving pocket depth more than 6mm deep and vertical infra bony defect after initial periodontal therapy, are selected.

Key exclusion criteria

Patients with following conditions are excluded from subjects: patients with pre-existing severe diseases such as diabetes mellitus, cardiovascular disease and autoimmune disease etc.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Hiromasa
Middle name
Last name Yoshie

Organization

Niigata University

Division name

Division of Periodontology

Zip code

951-8514

Address

2-5274 Gakkocho-Dori, Chuo-ku, Niigata, 951-8514 Japan

TEL

+81252272869

Email

yoshie@dent.niigata-u.ac.jp


Public contact

Name of contact person

1st name Yasuko
Middle name
Last name Nemoto

Organization

Niigata University

Division name

Division of Periodontology

Zip code

951-8514

Address

2-5274 Gakkocho-Dori, Chuo-ku, Niigata, 951-8514 Japan

TEL

+8125227871

Homepage URL


Email

yasuko@kyi.biglobe.ne.jp


Sponsor or person

Institute

Niigata University

Institute

Department

Personal name



Funding Source

Organization

Niigata University

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

Niigata University Medical and Dental Hospital

Address

1-757, Asahimachi-Dori, Chuo-ku, Niigata

Tel

025-227-2871

Email

kubota@dent.niigata-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

2013 Year 09 Month 11 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

40

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

2013 Year 08 Month 06 Day

Date of IRB

2013 Year 08 Month 07 Day

Anticipated trial start date

2013 Year 09 Month 12 Day

Last follow-up date

2017 Year 09 Month 12 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 09 Month 11 Day

Last modified on

2023 Year 09 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013691


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name