UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019811 |
|---|---|
| Receipt number | R000022891 |
| Scientific Title | A randamized control traials on the effect of denture cleaning between different methods |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2018/10/12 15:16:26 |
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Basic information
Public title
A randamized control traials on the effect of denture cleaning between different methods
Acronym
A randamized control traials on the effect of denture cleaning between different methods
Scientific Title
A randamized control traials on the effect of denture cleaning between different methods
Scientific Title:Acronym
A randamized control traials on the effect of denture cleaning between different methods
Region
| Japan |
Condition
Condition
edentulous
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the effect of the denture cleaning between different methods is compared.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient satisfaction(At Intervention and after intervention 3,4,7 weeks)
Key secondary outcomes
cost-effectiveness(At Intervention and after intervention 3,4,7 weeks)
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Instruct to dislodge denture and wash with denture brush under running water for 2 minutes after every meal and soak dentures in saline while sleeping in 3 weeks.
After 1 week washout period, instruct todislodge denture and wash with denture brush under running water for 2 minutes after every meal and soak dentures in denture cleanser, Polident, while sleeping in 3 weeks.
Interventions/Control_2
Instruct todislodge denture and wash with denture brush under running water for 2 minutes after every meal and soak dentures in denture cleanser, Polident, while sleeping in 3 weeks.
After 1 week washout period, instruct to dislodge denture and wash with denture brush under running water for 2 minutes after every meal and soak dentures in saline while sleeping in 3 weeks.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
edentulous
Key exclusion criteria
Metal denture user
Deteriorating general conditions
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yusuke Sato |
Organization
Tokyo Medical and Dental University
Division name
Graduate school of Medical and Dental Sciences, Gerodontology and Oral Rehabilitation
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5856
y.sato.gerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Sato |
Organization
Tokyo Medical and Dental University
Division name
Graduate school of Medical and Dental Sciences, Gerodontology and Oral Rehabilitation
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5856
Homepage URL
y.sato.gerd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental 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
Address
Tel
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
| 2016 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S1883195818300057?via%3Dihub
Number of participants that the trial has enrolled
Results
A combination of mechanical and chemical denture cleaning methods was more effective at cleaning dentures than the mechanical method alone. Even if denture cleaning improves denture hygiene, it may not increase patient satisfaction or OHRQoL.
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
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 16 | Day |
Last modified on
| 2018 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022891
