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Name
UMIN ID

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000024613
Receipt No. 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

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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
Institute Tokyo Medical and Dental University
Institute
Department

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
URL(English) 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


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