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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031383
Receipt No. R000035749
Scientific Title Comparison of the physiological properties of human periodontal-masseteric reflex evoked by canine and premolar stimulation
Date of disclosure of the study information 2018/04/25
Last modified on 2020/02/22

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Basic information
Public title Comparison of the physiological properties of human periodontal-masseteric reflex evoked by canine and premolar stimulation
Acronym Comparison of the physiological properties of human periodontal-masseteric reflex evoked by canine and premolar stimulation
Scientific Title Comparison of the physiological properties of human periodontal-masseteric reflex evoked by canine and premolar stimulation
Scientific Title:Acronym Comparison of the physiological properties of human periodontal-masseteric reflex evoked by canine and premolar stimulation
Region
Japan

Condition
Condition none (adult)
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify whether there is a functional difference in the sensory inputs from periodontal mechanoreceptors innervated in the canine and premolar
Basic objectives2 Others
Basic objectives -Others To clarify the existence of functional difference in the canine and premolar
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes We measure the masseter muscle activity with the mechanical stimulation in canine and premolar, and examine the reflex response.
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 Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 To measure masseter muscle activity using surface electrodes
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 All subjects has a full complement of natural teeth, without malocclusion, except for the absence of the third molars.
Key exclusion criteria A person who has any acute or chronic injury or systemic disease, or previous surgery related to the masticatory system.
Who has complain of symptoms of temporomandibular disorders.
A person who has any neurological problems, and take medication specifically intended to affect the musculoskeletal system.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name ONO
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Department of Orthodontic Science
Zip code 13-8549
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5529
Email t.ono.orts@tmd.ac.jp

Public contact
Name of contact person
1st name Hiroko
Middle name
Last name OHMORI
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Department of Orthodontic Science
Zip code 13-8549
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5529
Homepage URL
Email ohmori.orts@gmail.com

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Medical and Dental University
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel 03-5803-4085
Email info.bec@tmd.ac.jp

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 東京医科歯科大学大学院医歯学総合研究科(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 25 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 10
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 No longer recruiting
Date of protocol fixation
2018 Year 04 Month 25 Day
Date of IRB
2018 Year 04 Month 23 Day
Anticipated trial start date
2018 Year 04 Month 25 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 20 Day
Last modified on
2020 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035749

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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