UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056596 |
|---|---|
| Receipt number | R000064563 |
| Scientific Title | Effects of trehalose on halitosis |
| Date of disclosure of the study information | 2025/01/06 |
| Last modified on | 2024/12/27 21:58:59 |
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Basic information
Public title
Effects of trehalose on halitosis
Acronym
A cross-over design
Scientific Title
Effects of trehalose on halitosis
Scientific Title:Acronym
A cross-over design
Region
| Japan |
Condition
Condition
halitosis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of trehalose on halitosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
organoleptic test
Key secondary outcomes
oral wetness
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
spray with trehalose
Interventions/Control_2
spray without trehalose
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
xerostomia
volunteers who agreed to take part in the experiment after written informed consent
Key exclusion criteria
dental caries and/or sever periodontitis
pregnancy or suspected case of pregnancy
food allergy
inadequate participants
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Morita |
Organization
Okayama University
Division name
Department of Preventive Dentistry
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-6712
mmorita@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Morita |
Organization
Okayama University
Division name
Department of Preventive Dentistry
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-6712
Homepage URL
mmorita@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University
Address
2-5-1, Shikata-cho, Kiat-ku, Okayama
Tel
086-235-6938
mae6605@adm.okayama-u.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
| 2025 | Year | 01 | Month | 06 | 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
10
Results
After application of 10% trehalose by oral spray, the primary outcome (the organoleptic score) was decreased time-dependently. However, there were no significant difference between the trehalose and placebo groups. In secondary outcomes, immediately after trehalose spray application, oral moisture level increased and there was significant difference in amount of change from baseline between the trehalose and placebo groups. However, there are no significant differences in other variables.
Results date posted
| 2024 | Year | 12 | Month | 27 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The delay depends on data calculation and analyses.
Date of the first journal publication of results
| 2024 | Year | 12 | Month | 27 | Day |
Baseline Characteristics
volunteers
Participant flow
Consent to research > Assessed for eligibility
Adverse events
nothing
Outcome measures
organoleptic test
volatile sulfur compounds
oral moisture level
Plan to share IPD
NA
IPD sharing Plan description
NA
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 27 | Day |
Last modified on
| 2024 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064563
