UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of cognitive behavioral therapy in prosthodontic treatment:randomized controlled trial(RCT)
Title of the study (Brief title)	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	Kiyoshi Koyano
Organization	Fuclty of Dental Science,Kyushu university
Division name	Section of Implant and Rehabilitative Dentistry Devision of Rehabilitation
Address	3-1-1,maidashi,higashi-ku,fukuoka-shi,fukuoka-ken
TEL	092-642-6441
Email	n-tsuji@dent.kyushu-u.ac.jp

Public contact
Name of contact person	Nozomi Tsuji
Organization	Faculty of Dental Science,Kyushu university
Division name	Section of Implant and Rehabilitative Dentistry Devision of Rehabilitation
Address	3-1-1,maidashi,higashi-ku,fukuoka-shi,fukuoka-ken
TEL	092-642-6441
Homepage URL
Email	n-tsuji@dent.kyushu-u.ac.jp

Sponsor
Institute	Section of Implant and Rehabilitative Dentistry Devision of Rehabilitation Faculty of Dental Science,Kyushu university
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019794