UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020554
Receipt number 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 2022/01/17 10:12:09

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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 or person

Institute

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Institute

Department

Personal name



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

Value
https://center6.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