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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020554
Receipt No. R000023730
Scientific Title Clinical study of changes of the masticatory muscle activities before and after the dental implantation treatment
Date of disclosure of the study information 2016/01/13
Last modified on 2016/01/13

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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 Open public recruiting
Date of protocol fixation
2013 Year 10 Month 15 Day
Date of IRB
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
2016 Year 01 Month 13 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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