UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of the effect of prosthodontic treatment on mastication predominance in patients with unilateral posterior missing teeth
Title of the study (Brief title)	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	Kiyoshi Koyano
Organization	Faculty of Dental Science, Kyushu University
Division name	Section of Implant and Rehabilitative Dentistry, Division of Oral Rehabilitation
Address	3-1-1, Maidashi, Higashiku, Fukuoka
TEL	092-642-6441
Email	yamayo@dent.kyushu-u.ac.jp

Public contact
Name of contact person	Yo Yamasaki
Organization	Faculty of Dental Science, Kyushu University
Division name	Section of Implant and Rehabilitative Dentistry, Division of Oral Rehabilitation
Address	3-1-1, Maidashi, Higashiku, Fukuoka
TEL	092-642-6441
Homepage URL
Email	yamayo@dent.kyushu-u.ac.jp

Sponsor
Institute	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	Other
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	2016 Year 01 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023765