UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020630 |
|---|---|
| Receipt number | R000023765 |
| Scientific Title | Assessment of the effect of prosthodontic treatment on mastication predominance in patients with unilateral posterior missing teeth |
| Date of disclosure of the study information | 2016/01/19 |
| Last modified on | 2019/01/22 06:46:13 |
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Basic information
Public title
Assessment of the effect of prosthodontic treatment on mastication predominance in patients with unilateral posterior missing teeth
Acronym
The effect of prosthodontic treatment on mastication predominance
Scientific Title
Assessment of the effect of prosthodontic treatment on mastication predominance in patients with unilateral posterior missing teeth
Scientific Title:Acronym
The effect of prosthodontic treatment on mastication predominance
Region
| Japan |
Condition
Condition
missing teeth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of prosthodontic treatment on mastication predominance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
objective assessment of mastication predominance before and after therapy (3~6months)
Key secondary outcomes
subjective assessment of mastication predominance before and after therapy (3~6months)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
implant supported fixed partial denture
Interventions/Control_2
removable partial denture
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 over 20 years old with missing posterior teeth on one side, with no history of prosthodontic treatment, with opposing teeth that were natural teeth or fixed prosthetic devices.
Key exclusion criteria
those exhibiting systemic illness or dental disease with possible effects on mastication; those with jaw dysfunction and/or pain such as temporomandibular disorders; and those with compromised mental capacity due to dementia or other psychiatric diseases.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Koyano |
Organization
Faculty of Dental Science, Kyushu University
Division name
Section of Implant and Rehabilitative Dentistry, Division of Oral Rehabilitation
Zip code
Address
3-1-1, Maidashi, Higashiku, Fukuoka
TEL
092-642-6441
yamayo@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yo Yamasaki |
Organization
Faculty of Dental Science, Kyushu University
Division name
Section of Implant and Rehabilitative Dentistry, Division of Oral Rehabilitation
Zip code
Address
3-1-1, Maidashi, Higashiku, Fukuoka
TEL
092-642-6441
Homepage URL
yamayo@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Faculty of Dental Science, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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 | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 11 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 04 | 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
| 2016 | Year | 01 | Month | 19 | Day |
Last modified on
| 2019 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023765
| 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 |
