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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000047681
Receipt No. 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

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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
Email 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
Email hoshi@kdu.ac.jp

Sponsor
Institute Kanagawa Dental University
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053814

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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