UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050150 |
|---|---|
| Receipt number | R000057127 |
| Scientific Title | Practical Application Research of Periodontal Disease Risk Diagnosis Algorithm by Salivary Component Analysis |
| Date of disclosure of the study information | 2023/05/31 |
| Last modified on | 2023/05/31 15:29:03 |
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Basic information
Public title
Development research for practical application of periodontal disease risk diagnosis algorithm by saliva test
Acronym
Development of an algorithm for diagnosing periodontal disease risk by saliva testing
Scientific Title
Practical Application Research of Periodontal Disease Risk Diagnosis Algorithm by Salivary Component Analysis
Scientific Title:Acronym
Practical Application Research of Periodontal Disease Risk Diagnostic Algorithm
Region
| Japan |
Condition
Condition
Periodontal disease
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Diagnosis of periodontal disease is not suitable for health checkup projects involving more than 100 people per day, such as periodontal histology and X-rays. Saliva tests have been developed to address this problem, but they have not been widely used due to problems with diagnostic accuracy. The purpose of this study is to verify the diagnostic accuracy of a new periodontal disease risk diagnosis algorithm developed by combining quantitative salivary test values (leukocyte esterase, hemoglobin, and protein) with a quantitative PCR method that can quantify the amount of periodontal pathogens.
Basic objectives2
Others
Basic objectives -Others
The diagnostic accuracy of a new periodontal disease risk diagnostic algorithm developed by applying absorbance measurement technology to detect periodontal pathogens using quantitative PCR and quantitative test values from saliva samples will be compared to conventional periodontal disease tests to evaluate reliability.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Logistic regression equation with patient PISA actual values as the objective variable
The diagnostic criteria by PISA is that 100 or less is healthy, 100 to 500 is pre periodontal disease, and 600 or more is moderate periodontal disease. Therefore, PISA values obtained from each subject were logit-transformed and used as the objective variable, with PISA values of 100 and 600 as the cutoff values. The quantitative values of periodontal pathogens (Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, and Filifactor alocis) by quantitative PCR and SiLL-Ha's hemoglobin, leukocyte esterase and protein values are placed as explanatory variables and logistic regression equations are calculated.
Key secondary outcomes
Validation of diagnostic accuracy of logistic regression equations
The diagnostic accuracy of the logistic regression equation at each cutoff value will be tested by ROC analysis to detect diagnostic accuracy (accuracy, sensitivity, specificity, positive predictive value, and negative predictive value), by AUC determination, and by Hosmer-Lemeshow method to determine the fit of the regression model.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Diseases and conditions: Patients who meet the following criteria for periodontal disease
Periodontal disease: Patients with periodontal disease with at least one periodontal pocket of 4 mm or greater on periodontal histology.
(2) Age: 20 years old or older and less than 80 years old (at the time of registration)
(3) Gender: Any gender
Key exclusion criteria
Research subjects who, in the judgment of the dentist, would have difficulty participating in the study
Target sample size
100
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
022-717-8340
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 Ecological Dentistry Division of Operative 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
Masahiro Saito
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku Universuty
Address
2-1 Seiryo-cho, Aoba-ku, Sendai-shi, Miyagi 980-8575
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2023 | Year | 05 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non
Management information
Registered date
| 2023 | Year | 01 | Month | 26 | Day |
Last modified on
| 2023 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057127
