UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study of changes of the masticatory muscle activities before and after the dental implantation treatment
Acronym	Clinical study of the masticatory muscle activities before and after the dental implantation treatment
Scientific Title	Clinical study of changes of the masticatory muscle activities before and after the dental implantation treatment
Scientific Title:Acronym	Clinical study of the masticatory muscle activities before and after the dental implantation treatment
Region	Japan

Condition
Condition	Missing teeth
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to obtain new knowledge from EMG activities of the masticatory muscles before and after dental implantation treatment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The number and duration time of the masticatory muscles activities was compared between before dental implant fixture is embedded and after implant upper structure is fixed.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Occlusal rehabilitation with dental implant treatment
Interventions/Control_2
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	1) According to Eichner Index, A, B and C classification. 2) 20 years of age or over 3) Agreement to participate in this study after informed consent. 4) The patients who have a examination in the department of occlusion and denture prosthodontics at Okayama University Hospital and at Takeda Dental Clinic.
Key exclusion criteria	1) The patients who have been inserted a pacemaker into the heart. 2) Examiners judge that the patient is inappropriate to participate this study for safety.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shogo Minagi
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Occlusal and Oral Functional Rehabilitation
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525 JAPAN
TEL	+81-86-235-6687
Email	minagi@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shigehisa Kawakami
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Occlusal and Oral Functional Rehabilitation
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525 JAPAN
TEL	+81-86-235-6687
Homepage URL
Email	s-kawa-10@t.okadai.jp

Sponsor
Institute	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization	Department of Occlusal and Oral Functional Rehabilitation
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Takeda Dental Clinic
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	岡山大学大学院医歯薬学総合研究科咬合・義歯補綴科（岡山県），武田歯科医院（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 13 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	2013 Year 10 Month 15 Day
Date of IRB	2013 Year 10 Month 15 Day
Anticipated trial start date	2013 Year 10 Month 15 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 01 Month 13 Day
Last modified on	2022 Year 01 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023730