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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000046582
Receipt No. R000053135
Scientific Title Survey of the first visiting patients in a periodontics clinic
Date of disclosure of the study information 2022/01/07
Last modified on 2022/01/07

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Basic information
Public title Survey of the first visiting patients in a periodontics clinic
Acronym Survey of the first visiting patients in a periodontics clinic
Scientific Title Survey of the first visiting patients in a periodontics clinic
Scientific Title:Acronym Survey of the first visiting patients in a periodontics clinic
Region
Japan

Condition
Condition Periodontitis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to collect information on new patients who visited the periodontal clinic in Tokyo Medical and Dental University (TMDU) Hospital and to analyze whether there is a correlation between periodontal disease and systemic diseases, and smoking habits.
Basic objectives2 Others
Basic objectives -Others In recent years, the number of patients with various systemic diseases has increased due to the aging society. In addition, it has been reported that periodontal disease has an impact on systemic diseases such as diabetes and cardiovascular disease, as well as metabolic syndrome. There have been many reports from overseas on the relationship between periodontal disease and systemic diseases and metabolic syndrome, but the survey to reveal such relationships has not yet been conducted at TMDU hospital. For this reason, we will conduct a survey of patients who have firstly visited the periodontal clinic in TMDU hospital.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A cross-sectional survey of DMFT (number of caries teeth, missing teeth, and filled teeth), Community Periodontal Index of Treatment Needs (CPITN), and periodontal pocket depth (PPD) will be performed at the first visit.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria All patients who first visited the periodontal clinic at TMDU hospital
Key exclusion criteria none
Target sample size 4000

Research contact person
Name of lead principal investigator
1st name Koji
Middle name
Last name Mizutani
Organization Tokyo Medical and Dental University
Division name Department of Periodontology
Zip code 113-8549
Address Yushima 1-5-45, Bunkyo, Tokyo
TEL 03-5803-5488
Email mizuperi@tmd.ac.jp

Public contact
Name of contact person
1st name Koji
Middle name
Last name Mizutani
Organization Tokyo Medical and Dental University
Division name Department of Periodontology
Zip code 113-8549
Address Yushima 1-5-45, Bunkyo, Tokyo
TEL 03-5803-5488
Homepage URL
Email mizuperi@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Medical and Dental University
Address Yushima 1-5-45, Bunkyo, Yushima
Tel 03-5803-5488
Email mizuperi@tmd.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 1085
Org. issuing International ID_1 the Research Ethics Committee of Tokyo Medical and Dental University Dental Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京医科歯科大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2022 Year 01 Month 07 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 Suspended
Date of protocol fixation
2014 Year 08 Month 04 Day
Date of IRB
2014 Year 08 Month 04 Day
Anticipated trial start date
2014 Year 08 Month 05 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We collect the cross-sectional information on medical interviews and oral examinations performed on patients who visited the periodontic clinic in TMDU hospital.

Management information
Registered date
2022 Year 01 Month 07 Day
Last modified on
2022 Year 01 Month 07 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053135

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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