UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056738 |
|---|---|
| Receipt number | R000064608 |
| Scientific Title | Effect of different denture cleaning methods on the reduction of biofilms on complete denture with resilient denture liners: a randomized controlled trial |
| Date of disclosure of the study information | 2025/01/16 |
| Last modified on | 2025/01/16 21:49:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Bacteria eliminating effect of denture cleaning methods on resilient denture liners
Acronym
Bacteria elimination from resilient denture liners
Scientific Title
Effect of different denture cleaning methods on the reduction of biofilms on complete denture with resilient denture liners: a randomized controlled trial
Scientific Title:Acronym
Randomized controlled trial of denture cleaning methods
Region
| Japan |
Condition
Condition
Edentulism
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study of purpose is to Investigate effective cleaning methods for biofilms formed on resilient denture relines by a cross-over randomised clinical trial.
Basic objectives2
Others
Basic objectives -Others
Investigating differences in bacterial adhesion between different types of reline materials.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CFU
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Brushing
Interventions/Control_2
Chemical cleansing
Interventions/Control_3
Brushing and Chemical cleansing
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
Complete denture wearers
Key exclusion criteria
1. Patients who cannot read or write Japanese due to physical reasons such as dementia or blindness.
2. Patients with metal-based maxillary complete denture.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Suguru |
| Middle name | |
| Last name | Kimoto |
Organization
Aichi Gakuin University School of Dentistry
Division name
Department of Gerodontology and Home Care Dentistry
Zip code
464-8651
Address
2-11 Suemoritouri Chikusaku Nagoya Aichi 464-8651 Japan
TEL
+81-52-759-2154
kimoto@dpc.agu.ac.jp
Public contact
Name of contact person
| 1st name | Suguru |
| Middle name | |
| Last name | Kimoto |
Organization
Aichi Gakuin University School of Dentistry
Division name
Department of Gerodontology and Home Care
Zip code
464-8651
Address
2-11 Suemoritouri Chikusaku Nagoya Aichi 464-8651 Japan
TEL
052-759-2154
Homepage URL
kimoto@dpc.agu.ac.jp
Sponsor or person
Institute
Aichi Gakuin University
Institute
Department
Personal name
Kimoto Suguru
Funding Source
Organization
Department of Gerodontology and Home Care
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
School of Dentistry Aichi Gakuin University
Address
2-11 Suemoritouri Chikusaku Nagoya Aichi 464-8651 Japan
Tel
052-759-2154
kimoto@dpc.agu.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 | 16 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 25 | 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
| 2025 | Year | 01 | Month | 16 | Day |
Last modified on
| 2025 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064608
