UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017086 |
|---|---|
| Receipt number | R000019794 |
| Scientific Title | Effects of cognitive behavioral therapy in prosthodontic treatment:randomized controlled trial(RCT) |
| Date of disclosure of the study information | 2015/04/10 |
| Last modified on | 2017/03/09 12:19:18 |
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Basic information
Public title
Effects of cognitive behavioral therapy in prosthodontic treatment:randomized controlled trial(RCT)
Acronym
Effects of cognitive behavioral therapy in prosthodontic treatment
Scientific Title
Effects of cognitive behavioral therapy in prosthodontic treatment:randomized controlled trial(RCT)
Scientific Title:Acronym
Effects of cognitive behavioral therapy in prosthodontic treatment
Region
| Japan |
Condition
Condition
free-end missing teeth in molar region
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
comparison of improvement
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
improvement in subjective evaluations before and after the treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
interventions:cognitive behavioral therapy
Interventions/Control_2
control:providing explanations about treatment
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
.subjects who have free end missing teeth in molar region in one or both sides,and receive prosthodontic treatment with a removable partial denture
.subjects who don't wear a removable partial denture or have missing teeth in opposing dental arch that require prosthodontic treatment
Key exclusion criteria
.subjects suffering serious mental illness
.subjects who cannot fill out a questionnaire for disorientation
.pregnant and breast-feeding women,and women planning to get pregnant during this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Koyano |
Organization
Fuclty of Dental Science,Kyushu university
Division name
Section of Implant and Rehabilitative Dentistry Devision of Rehabilitation
Zip code
Address
3-1-1,maidashi,higashi-ku,fukuoka-shi,fukuoka-ken
TEL
092-642-6441
n-tsuji@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nozomi Tsuji |
Organization
Faculty of Dental Science,Kyushu university
Division name
Section of Implant and Rehabilitative Dentistry Devision of Rehabilitation
Zip code
Address
3-1-1,maidashi,higashi-ku,fukuoka-shi,fukuoka-ken
TEL
092-642-6441
Homepage URL
n-tsuji@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Section of Implant and Rehabilitative Dentistry Devision of Rehabilitation
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
Japanese Governmental office
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 | 04 | Month | 10 | 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
| 2015 | Year | 03 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 15 | 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 | 04 | Month | 09 | Day |
Last modified on
| 2017 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019794
