UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053923 |
|---|---|
| Receipt number | R000061330 |
| Scientific Title | Large-scale study aimed at the practical implementation of an algorithm for diagnosing periodontal disease risk |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/03/21 12:45:49 |
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Basic information
Public title
Large-scale study aimed at the practical implementation of an algorithm for diagnosing periodontal disease risk
Acronym
Large-scale study aimed at the practical implementation of an algorithm for diagnosing periodontal disease risk
Scientific Title
Large-scale study aimed at the practical implementation of an algorithm for diagnosing periodontal disease risk
Scientific Title:Acronym
Large-scale study aimed at the practical implementation of an algorithm for diagnosing periodontal disease risk
Region
| Japan |
Condition
Condition
Periodontal disease
Classification by specialty
| Dental medicine | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of a screening kit in detecting severe periodontal disease (Stage III, Group C, and Stage VI, Group C), we will combine quantitative data on periodontal pathogens (Porphyromonas gingivalis, Tannerella forsythia, and Tannerella forsythia) present in saliva with blood biomarker values (LDL, CRP, WBC, HbA1c). This study aims to evaluate the diagnostic accuracy of the screening kit through a large-scale clinical study involving 1,000 subjects.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Check the accuracy of the target rate for subjects diagnosed with severe periodontal disease by the Severe Periodontal Disease Screening Kit.
Key secondary outcomes
not applicable
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A total of 1,000 participants will be targeted, including those working at Midtown Clinic (Tokyo Midtown Clinic, Nihonbashi Muromachi Mitsui Tower Midtown Clinic) and Shinkokai (Shinko Clinic, Shinko Clinic Annex, Oval Code Health Checkup Clinic, Seravi Shinbashi Clinic, Hamamatsucho Hama Site Clinic, Hamacho Koen Clinic, Tokyo Diamond Building Clinic, Tohpura Health Checkup Clinic, Sendai General Health Checkup Clinic).
Key exclusion criteria
Research subjects who, in the judgment of the physician, would have difficulty participating in the study
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Saito |
Organization
Tohoku University
Division name
Department of Dentistry
Zip code
980-8575
Address
4-1 Seiryo-cho, Aoba-ku, Sendai City
TEL
0227178340
masahiro.saito.c5@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Saito |
Organization
Tohoku University
Division name
Department of Dentistry
Zip code
980-8575
Address
4-1, Seiryo-machi. Aoba-Ku, Sendai, Miyagi 980-8575, Japan
TEL
0227178340
Homepage URL
masahiro.saito.c5@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Saito Masahiro
Funding Source
Organization
No
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
Tohoku Universuty
Address
4-1, Seiryo-machi. Aoba-Ku, Sendai, Miyagi 980-8575, Japan
Tel
022-728-4105
https://www.acto.hosp.tohoku.ac.jp/faqmgr/tadao3.cgi
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
| 2024 | Year | 06 | 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
| 2024 | Year | 02 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing in particular
Management information
Registered date
| 2024 | Year | 03 | Month | 21 | Day |
Last modified on
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061330
