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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016650
Receipt No. 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

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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
Email 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
Email digiflex@dent.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Dentistry
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019326

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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