UMIN-CTR Clinical Trial

Basic information
Public title	Evaluating age-related change in periodontal mechanoreceptors using somatosensory evoked magnetic fields
Acronym	Evaluating age-related change in periodontal mechanoreceptors using somatosensory evoked magnetic fields
Scientific Title	Evaluating age-related change in periodontal mechanoreceptors using somatosensory evoked magnetic fields
Scientific Title:Acronym	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	1st name Keiichi Middle name Last name Sasaki
Organization	Tohoku University Graduate School of Dentistry
Division name	Advanced Prosthetic Dentistry
Zip code	980-8575
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	1st name Hiroki Middle name Last name Hihara
Organization	Tohoku University Graduate School of Dentisitry
Division name	Advanced Prosthetic Dentistry
Zip code	980-8575
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)

IRB Contact (For public release)
Organization	Ethical committee of the Tohoku University Graduate School of Dentistry
Address	4-1 Seiryo-machi, Aoba-ku,Sendai,980-8575,Japan
Tel	022-717-8244
Email	den-syom@grp.tohoku.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

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 01 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	20
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	2018 Year 11 Month 12 Day
Date of IRB	2018 Year 10 Month 24 Day
Anticipated trial start date	2018 Year 12 Month 01 Day
Last follow-up date	2022 Year 10 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 11 Month 12 Day
Last modified on	2022 Year 11 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039754