UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055399 |
|---|---|
| Receipt number | R000063315 |
| Scientific Title | Investigation of antimicrobial effects and oral cleanliness maintenance effects of dentures by the denture coating agent with cross-over test |
| Date of disclosure of the study information | 2024/09/03 |
| Last modified on | 2025/04/25 08:28:47 |
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Basic information
Public title
Investigation of antimicrobial effects and oral cleanliness maintenance effects of dentures by the denture coating agent
Acronym
Effects of oral cleanliness maintenance by the denture coating
Scientific Title
Investigation of antimicrobial effects and oral cleanliness maintenance effects of dentures by the denture coating agent with cross-over test
Scientific Title:Acronym
Effects of oral cleanliness maintenance by the denture coating: a cross-over test
Region
| Japan |
Condition
Condition
oral biofilm infection, oral candidasis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the antimicrobial effect of denture coatings, as well as the secondary oral hygiene maintenance effect, by investigating changes before and after the use of denture coatings in the amount of plaque adhered to dentures and the amount of bacteria and fungi in denture adhered plaque and tongue coating.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reduction of oral bacterial and oral Candida counts by application of coating to dentures.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Without denture coating to with denture coating
Interventions/Control_2
With denture coating to without denture coating
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Elderly nursing home residents and denture wearers
(2) Patients who fully understand this research plan and are able to give their consent (and that of their surrogate).
(3) Patients who are 65 years of age or older at the time consent is obtained (elderly persons requiring long-term care)
(4) Patients who are under regular oral hygiene management (oral hygiene management once a month)
Key exclusion criteria
(1) Patients whose consent could not be obtained
(2) Other patients whom the investigator deems inappropriate as research subjects
(3) Patients undergoing dental treatment (caries, denture fabrication, etc)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiromitsu |
| Middle name | |
| Last name | Morita |
Organization
Fukuoka Dental College
Division name
Section of Dentistry for the Disabled, Department of Oral Growth and Development
Zip code
8140193
Address
2-15-1 Tamura, Sawara-ku, Fukuoka
TEL
0928010425
morita@fdcnet.ac.jp
Public contact
Name of contact person
| 1st name | Hiromitsu |
| Middle name | |
| Last name | Morita |
Organization
Fukuoka Dental College
Division name
Section of Dentistry for the Disabled, Department of Oral Growth and Development
Zip code
8140193
Address
2-15-1 Tamura, Sawara-ku, Fukuoka
TEL
0928010425
Homepage URL
morita@fdcnet.ac.jp
Sponsor or person
Institute
Fukuoka Dental College
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Dental College
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
Fukuoka Dental College
Address
2-15-1 Tamura, Sawara-ku, Fukuoka
Tel
0928010425
shomu@fdcnet.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
| 2024 | Year | 09 | Month | 03 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 03 | 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
Management information
Registered date
| 2024 | Year | 09 | Month | 02 | Day |
Last modified on
| 2025 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063315
