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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034868
Receipt No. R000039754
Official scientific title of the study Evaluating age-related change in periodontal mechanoreceptors using somatosensory evoked magnetic fields
Date of disclosure of the study information 2018/12/01
Last modified on 2018/11/12

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Basic information
Official scientific title of the study Evaluating age-related change in periodontal mechanoreceptors using somatosensory evoked magnetic fields
Title of the study (Brief title) Evaluating age-related change in periodontal mechanoreceptors using somatosensory evoked magnetic fields
Region
Japan

Condition
Condition Adults
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to detect the age-related change of SEFs of tactile stimulation of teeth (periodontal ligament).
Basic objectives2 Others
Basic objectives -Others To examine whether SEFs can be objective evaluation of paresthesias etc.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ECD moment of the first component for SEFs of periodontal ligament
Key secondary outcomes Latency of the first and second component for SEFs of periodontal ligament
ECD moment of the second component for SEFs of periodontal ligament

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Tactile stimulation was applied by tapping to the left side of canine and first molar teeth.
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.Men and Women over 20 years of age at the time of obtaining informed consent
2.Subjects who have canine and first molar in left side of madiblar and maxillary
3.Subjects who agreed with the document to participate in this research
4.Subjects who do not have communication disorder
Key exclusion criteria 1.Subjects who have oral mucosal disease
2.Subjects with severe vomiting reflex
3.Subjects who have C2 caties and more teeth which have >=6mm periodontal pocket with bleednigs
4.Subjects who have judged disqualification by MRI/MEG inspection check sheet
5.Subjects who have judged that it is difficlt to participate in this study
Target sample size 40

Research contact person
Name of lead principal investigator Keiichi Sasaki
Organization Tohoku University Graduate School of Dentistry
Division name Advanced Prosthetic Dentistry
Address 4-1 Seiryo-machi, Aoba-ku,Sendai,980-8575,Japan
TEL 022-717-8368
Email keii@dent.tohoku.ac.jp

Public contact
Name of contact person Hiroki Hihara
Organization Tohoku University Hospital
Division name Advanced Prosthetic Dentistry
Address 4-1 Seiryo-machi, Aoba-ku,Sendai,980-8575,Japan
TEL 022-717-8369
Homepage URL
Email hihara@dent.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Dentistry
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)

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
2018 Year 12 Month 01 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 12 Day
Anticipated trial start date
2018 Year 12 Month 01 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 Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 12 Day
Last modified on
2018 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039754

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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