UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024613
Receipt number R000028318
Scientific Title Research on usefulness of dental endoscopy for subgingival calculus detection
Date of disclosure of the study information 2016/10/29
Last modified on 2019/05/15 08:16:26

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Basic information

Public title

Research on usefulness of dental endoscopy for subgingival calculus detection

Acronym

Research on usefulness of dental endoscopy for subgingival calculus detection

Scientific Title

Research on usefulness of dental endoscopy for subgingival calculus detection

Scientific Title:Acronym

Research on usefulness of dental endoscopy for subgingival calculus detection

Region

Japan


Condition

Condition

Periodontitis

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the availability of dental endoscopy for subgingival calculus

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Presence of subgingival calculus

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

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

Device,equipment

Interventions/Control_1

To evaluate the presence of subgingival calculus with dental endoscopy

Interventions/Control_2

To evaluate the presence of subgingival calculus with periodontal probe

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

The person with periodontitis who has periodontal pocket with more than 4 mm depth at least one tooth.

Key exclusion criteria

The person with systemic infectious disease

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Akira
Middle name
Last name Aoki

Organization

Tokyo Medical and Dental University

Division name

Department of Periodontology

Zip code

113-8510

Address

1-5-45 Yushima Bunkyo-ku Tokyo Japan

TEL

03-5803-5488

Email

aoperi@tmd.ac.jp


Public contact

Name of contact person

1st name Akira
Middle name
Last name Aoki

Organization

Tokyo Medical and Dental University

Division name

Department of Periodontology

Zip code

113-8510

Address

1-5-45 Yushima Bunkyo-ku Tokyo Japan

TEL

03-5803-5488

Homepage URL


Email

aoperi@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Morimura Dental Company

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee of the Faculty of Dentistry, TMDU

Address

1-5-45 Yushima Bunkyo-ku Tokyo Japan

Tel

03-5803-5404

Email

d-hyoka.adm@tmd.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

東京医科歯科大学歯学部附属病院(東京都)


Other administrative information

Date of disclosure of the study information

2016 Year 10 Month 29 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

10

Results

Compared with the periodontal probe, the dental endoscope showed significant higher detection rate of dental calculus.

Results date posted

2019 Year 05 Month 15 Day

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

Main results already published

Date of protocol fixation

2016 Year 08 Month 05 Day

Date of IRB

2016 Year 08 Month 14 Day

Anticipated trial start date

2016 Year 12 Month 01 Day

Last follow-up date

2020 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

2016 Year 10 Month 28 Day

Last modified on

2019 Year 05 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028318


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name