UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031164 |
|---|---|
| Receipt number | R000035529 |
| Scientific Title | The effectiveness of porcelain teeth in complete dentures: non-blind randomized controlled trial |
| Date of disclosure of the study information | 2018/02/06 |
| Last modified on | 2018/06/12 09:26:27 |
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Basic information
Public title
The effectiveness of porcelain teeth in complete dentures: non-blind randomized controlled trial
Acronym
The effectiveness of porcelain teeth in complete dentures: non-blind randomized controlled trial
Scientific Title
The effectiveness of porcelain teeth in complete dentures: non-blind randomized controlled trial
Scientific Title:Acronym
The effectiveness of porcelain teeth in complete dentures: non-blind randomized controlled trial
Region
| Japan |
Condition
Condition
Edentulous Patients
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of porcelain teeth in complete dentures
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral health related Quality of Life (OHIP-EDENT)
(3months after insertion of complete dentures)
Key secondary outcomes
satisfaction
masticatory performance
occlusal force
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
porcelain teeth
Interventions/Control_2
hard resin teeth
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with complete dentures
Key exclusion criteria
severe alveolar rigde resorption, Maxillofacial Prothetics, severe xerostomia
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuro Yokoyama |
Organization
Graduate school of Dental Medicine,Hokkaido University
Division name
Department of Oral functional Prothodontics
Zip code
Address
Nishi-7, Kita-13, Kita-Ku, Sapporo, Japan
TEL
011-706-4270
yokoyama@den.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshifumi Nogawa |
Organization
Hokkaido University Hospital
Division name
Clinical research and medical innovation center
Zip code
Address
Nishi-5, Kita-14, Kita-Ku, Sapporo, Japan
TEL
011-706-7935
Homepage URL
t.nogawa@den.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Shofu Inc.
Organization
Division
Category of Funding Organization
Profit organization
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 06 | 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
| 2018 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | 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
| 2018 | Year | 02 | Month | 06 | Day |
Last modified on
| 2018 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035529
