UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047681 |
|---|---|
| Receipt number | R000053814 |
| Scientific Title | Comprehensive Analysis of Metabolites in Saliva Induced by Occlusal Chewing Stimulation |
| Date of disclosure of the study information | 2022/05/09 |
| Last modified on | 2022/05/09 08:07:36 |
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Basic information
Public title
Comprehensive Analysis of Metabolites in Saliva Induced by Occlusal Chewing Stimulation
Acronym
Comprehensive Analysis of Metabolites in Saliva Induced by Occlusal Chewing Stimulation
Scientific Title
Comprehensive Analysis of Metabolites in Saliva Induced by Occlusal Chewing Stimulation
Scientific Title:Acronym
Comprehensive Analysis of Metabolites in Saliva Induced by Occlusal Chewing Stimulation
Region
| Japan |
Condition
Condition
oral candidiasis
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Saliva is interconnected with the whole body via the nervous and vascular systems, and has been pointed out to be related to systemic diseases. In this study, saliva samples will be collected from patients and analyzed for metabolites in order to explore the relationship between saliva and diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Saliva volume and salivary metabolites in resting saliva and stimulated saliva collected on Monday and Tuesday mornings
Key secondary outcomes
Questionnaire of oral symptoms (VAS)
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
| 60 | years-old | < |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cognitively intact men and women, 60 years of age and older, with or without prosthetic devices
Key exclusion criteria
Patients on antifungal medications
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Kimoto |
Organization
Prosthodontics
Division name
Department of Crown and Bridge Prosthodontics
Zip code
238-8580
Address
82 Inaoka-cho, Yokosuka City, Kanagawa Prefecture
TEL
0468228751
k.kimoto@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Hoshi |
Organization
Prosthodontics
Division name
Department of Crown and Bridge Prosthodontics
Zip code
238-8580
Address
82 Inaoka-cho, Yokosuka City, Kanagawa Prefecture
TEL
0468228751
Homepage URL
hoshi@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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 College Research Ethics Review Committee
Address
82 Inaoka-cho, Yokosuka City, Kanagawa Prefecture
Tel
0468228751
kenkyo@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
| 2022 | Year | 05 | Month | 09 | 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
65
Results
Significant differences were observed for five metabolites in resting saliva and six metabolites in stimulated saliva compared to the control group.
Results date posted
| 2022 | Year | 05 | Month | 09 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Because we are looking for additional participants.
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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 13 | 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
This study will be a cross-sectional study. The subjects were all patients who visited our university hospital between May 2020 and April 2022 and met the selection criteria. The measures included resting saliva volume and stimulated saliva volume. A questionnaire on oral symptoms was also administered.
Management information
Registered date
| 2022 | Year | 05 | Month | 09 | Day |
Last modified on
| 2022 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053814
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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