UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062777 |
|---|---|
| Receipt number | R000070944 |
| Scientific Title | Establishment of a Dental Approach to the Pathogenesis of Coronary Artery Disease |
| Date of disclosure of the study information | 2026/09/10 |
| Last modified on | 2026/09/02 08:58:03 |
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Basic information
Public title
Establishment of Diagnostic Methods for Cardiovascular Diseases in Dentistry
Acronym
Establishment of a Novel Diagnostic Method for Cardiovascular Disease
Scientific Title
Establishment of a Dental Approach to the Pathogenesis of Coronary Artery Disease
Scientific Title:Acronym
Establishment of a Dental Approach to Coronary Artery Diseas
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to biochemically elucidate the potential linkage between periodontitis and coronary artery disease (CAD), two distinct organ-specific conditions, via metabolic and inflammatory pathways, using salivary metabolites. Saliva is a dynamic biofluid that reflects not only local oral pathologies but also systemic metabolic states, making it a valuable source for capturing pathophysiological connections between remote organs. By comprehensively analyzing the salivary metabolome of patients with periodontitis and CAD, this study seeks to extract metabolic intersections between these diseases and reconstruct their pathogenic mechanisms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary Metabolome Analysis
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients receiving outpatient care or hospitalized for coronary artery disease (CAD).
Key exclusion criteria
Patients unable to communicate.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Hoshi |
Organization
Kanagawa Dental University
Division name
Department of Oral Digital Science
Zip code
238-8580
Address
82 Inaokacho, Yokosuka, Kanagawa
TEL
046-822-8751
hoshi@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Hoshi |
Organization
Kanagawa Dental University
Division name
Department of Oral Digital Science
Zip code
238-8580
Address
82 Inaokacho, Yokosuka, Kanagawa
TEL
046-822-8751
Homepage URL
hoshi@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Sciety for the Promotion of Sceience
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
Kanagawa Dental University
Address
82 Inaokacho, Yokosuka, Kanagawa
Tel
046-822-8751
kdurinri@kdu.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 10 | 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
| 2026 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter observational study involving minor invasive procedures.
Management information
Registered date
| 2026 | Year | 09 | Month | 02 | Day |
Last modified on
| 2026 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070944
