UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034868
Receipt number R000039754
Scientific Title 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 2022/11/15 09:53:22

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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 or person

Institute

Tohoku University Graduate School of Dentistry

Institute

Department

Personal name



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

Value
https://center6.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