UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007310 |
|---|---|
| Receipt number | R000008439 |
| Scientific Title | A cross-over trial on efficacy of clasp-retained dentures and dentures using polyethylene terephthalate in patients with partially edentulous dentition |
| Date of disclosure of the study information | 2012/02/20 |
| Last modified on | 2018/09/07 15:27:29 |
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Basic information
Public title
A cross-over trial on efficacy of clasp-retained dentures and dentures using polyethylene terephthalate in patients with partially edentulous dentition
Acronym
A clinical trial on efficacy of Polyethylene RPD
Scientific Title
A cross-over trial on efficacy of clasp-retained dentures and dentures using polyethylene terephthalate in patients with partially edentulous dentition
Scientific Title:Acronym
A clinical trial on efficacy of Polyethylene RPD
Region
| Japan |
Condition
Condition
Partially edentulous arch
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify efficacy of RPDs using polyethylene
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Oral Health-related Quality of Life
Key secondary outcomes
Patient satisfaction
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Removable partial denture with clasp retainers
Interventions/Control_2
Removable partial denture using polyethylene terephthalate
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Plan to be treated with new removable partial denture(RPD)
- Having interest in esthetic RPDs
- Kennedy Class I, II, or III dental arches with few missing teeth
- Presence of bilateral occlusal support
Key exclusion criteria
- Severe resorbed alveolar ridge
- Remaining teeth show probing pocket depth (>= 4mm), tooth mobility (>= 2 degree) or presence of bleeding on probing.
- Poor oral hygiene (PCR > 20%)
- Interim RPD for implant-supported denture
- Presence of bruxism
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Fueki |
Organization
Tokyo Medical and Dental University
Division name
Graduate school, Removable partial denture prosthodontics
Zip code
Address
1-5-45, Yushima 1-chome, Bunkyo-Ku, Tokyo, 113-8549, Japan
TEL
03-5803-5514
kunfu.rpro@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Fueki |
Organization
Tokyo Medical and Dental University
Division name
Graduate school, Removable partial denture prosthodontics
Zip code
Address
1-5-45, Yushima 1-chome, Bunkyo-Ku, Tokyo, 113-8549, Japan
TEL
03-5803-5514
Homepage URL
kunfu.rpro@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
東京医科歯科大学歯学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/28196287
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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 16 | Day |
Last modified on
| 2018 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008439
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
