UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057094 |
|---|---|
| Receipt number | R000065256 |
| Scientific Title | Examination of the effect of mucosal protective denture adhesives on denture wearers with dry mouth |
| Date of disclosure of the study information | 2025/02/20 |
| Last modified on | 2026/02/20 17:38:21 |
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Basic information
Public title
Examination of the effect of mucosal protective denture adhesives on denture wearers with dry mouth
Acronym
Examination of the effect of mucosal protective denture adhesives on denture wearers with dry mouth
Scientific Title
Examination of the effect of mucosal protective denture adhesives on denture wearers with dry mouth
Scientific Title:Acronym
Examination of the effect of mucosal protective denture adhesives on denture wearers with dry mouth
Region
| Japan |
Condition
Condition
denture wearers
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of a denture adhesive that contains dietary ingredients as a mucosal protective agent on denture wearers with dry mouth
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Denture retention
2 weeks after from using
Key secondary outcomes
masticatory performance, occlusal force, oral moisture level, denture satisfaction
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Mucosa-protecting denture adhesive with edible ingredients as the main ingredient
Interventions/Control_2
Carboxymethylcellulose-based denture adhesive
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
Edentulous older adults wearing complete dentures without occlusal problems more than one month
Those whose oral moisture level measured by the oral moisture checker is less than 27
Key exclusion criteria
Those with food allergies
Those with eating and swallowing disorders
Those with communication difficulties
Those who are unable to undergo oral function examinations
Those who have used denture adhesives within the past three months
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Ryu |
Organization
Tokyo Dental College
Division name
Department of Removable Prosthodontics and Gerodontology
Zip code
1010061
Address
2-9-18 Kandamisaki-cho, Chiyoda-ku, Tokyo
TEL
0363809201
ryum@tdc.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Ryu |
Organization
Tokyo Dental College
Division name
Department of Removable Prosthodontics and Gerodontology
Zip code
1010061
Address
2-9-18 Kandamisaki-cho, Chiyoda-ku, Tokyo
TEL
0363809201
Homepage URL
ryum@tdc.ac.jp
Sponsor or person
Institute
Tokyo Dental College
Institute
Department
Personal name
Masahiro Ryu
Funding Source
Organization
Tokyo Dental College
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Dental College
Address
2-9-18 Kandamisaki-cho, Chiyoda-ku, Tokyo
Tel
0363809114
drinri@tdc.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
東京歯科大学水道橋病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 20 | 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
| 2022 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 20 | Day |
Last modified on
| 2026 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065256
