UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016650 |
|---|---|
| Receipt number | R000019326 |
| Scientific Title | Crossover trial comparing the clinical results of complete dentures with the biofunctional prosthetic system and conventional procedures. |
| Date of disclosure of the study information | 2015/02/27 |
| Last modified on | 2015/02/26 19:18:47 |
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Basic information
Public title
Crossover trial comparing the clinical results of complete dentures with the biofunctional prosthetic system and conventional procedures.
Acronym
Comparison of the BPS and conventional procedures
Scientific Title
Crossover trial comparing the clinical results of complete dentures with the biofunctional prosthetic system and conventional procedures.
Scientific Title:Acronym
Comparison of the BPS and conventional procedures
Region
| Japan |
Condition
Condition
Edentulous
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this trial was to evaluate the clinical acceptability of complete dentures fabricated using the biofunctional prosthetic system (BPS) compared with conventional fabrication methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral Health-Related Quality of Life (OHR-QoL)
Denture satisfaction
Denture comparison questionnaire
Number of adjustments
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Fabricating the new set of the complete dentures with BPS
Interventions/Control_2
Fabricating the new set of the complete dentures with conventional procedure
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
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(a) healthy adult patient requiring a new set of complete dentures; (b) complete dentures worn for at least 3 years previously; and (c) patient is mentally receptive
Key exclusion criteria
(a) Participants with dysfunction disorders of the masticatory system, debilitating systemic disease or oral mucosal disease.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken-ichi Matsuda |
Organization
Osaka University Graduate School of Dentistry
Division name
Department of Prosthodontics,Gerodontology and Oral Rehabilitation
Zip code
Address
1-8 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-2954
digiflex@dent.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken-ichi Matsuda |
Organization
Osaka University Graduate School of Dentistry
Division name
Department of Prosthodontics,Gerodontology and Oral Rehabilitation
Zip code
Address
1-8 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-2954
Homepage URL
digiflex@dent.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 02 | Month | 27 | 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
Completed
Date of protocol fixation
| 2010 | Year | 08 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | 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 | 02 | Month | 26 | Day |
Last modified on
| 2015 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019326
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
