UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031657
Receipt number R000036154
Scientific Title Application of Dental Optical Coherence Tomography to Periodontal Tissues.
Date of disclosure of the study information 2018/04/01
Last modified on 2018/03/09 17:37:03

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Basic information

Public title

Application of Dental Optical Coherence Tomography to Periodontal Tissues.

Acronym

Applicaton of Dental OCT to Periodontal Tissues

Scientific Title

Application of Dental Optical Coherence Tomography to Periodontal Tissues.

Scientific Title:Acronym

Applicaton of Dental OCT to Periodontal Tissues

Region

Japan


Condition

Condition

Periodontitis

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluate sound periodontium and periodontally affected periodontium using OCT.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Acquired OCT images and clinical status (Plaque Index, Gingival Index, Probing Pocket Depth, Bleeding on Probing, Mobility).

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

Volunteers with sound periodontium

Interventions/Control_2

Patients in department of periodontology, Tokyo Medical and Dental Hospital

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

30 volunteers with sound periodontium.
30 patients in department of peridontology, Tokyo Medical and Dental hospital.

Key exclusion criteria

Patient with infectious diseases such as HBV, HCV, HIV.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Aoki

Organization

Graduate School of Tokyo Medical and Dental University

Division name

Department of Periodontology

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510

TEL

0358035488

Email

aoperi@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akira Aoki

Organization

Graduate School of Tokyo Medical and Dental University

Division name

Department of Periodontology

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510

TEL

0358035488

Homepage URL


Email

aoperi@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Department of Periodontology, Graduate School of Tokyo Medical and Dental 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


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

2018 Year 04 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

Preinitiation

Date of protocol fixation

2018 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 04 Month 01 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

2018 Year 03 Month 09 Day

Last modified on

2018 Year 03 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036154


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name