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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032912
Receipt No. R000037526
Official scientific title of the study Evaluation of pain in the area of the maxillary oral cavity - Study by current perception threshold -
Date of disclosure of the study information 2018/06/07
Last modified on 2018/06/07

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Basic information
Official scientific title of the study Evaluation of pain in the area of the maxillary oral cavity - Study by current perception threshold -
Title of the study (Brief title) Evaluation of pain in the area of the maxillary oral cavity
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 was to investigate current perception threshold and pain threshold of mandibular mucosa using electrical stimulation.
Basic objectives2 Others
Basic objectives -Others Pain after denture wearing
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Current perception threshold
Key secondary outcomes Pain threshold

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Only healthy individuals were included in the study.
Key exclusion criteria 1. general health problems that could affect the measurement of nerve activity (e.g., trigeminal neuralgia or post herpetic neuralgia)
2. pacemaker wearers
3. It is a person with the past of the operation on mandible
4. obvious cognitive impairment; and
5. Pregnant woman
6. a lack of understanding of written or spoken Japanese
Target sample size 100

Research contact person
Name of lead principal investigator Kimoto Suguru
Organization Nihon University School of Dentistry at Matsudo
Division name Removable prosthodontics
Address sakaetyounishi 2-870-1, Matsudo-Shi, Tiba
TEL 047-368-6111
Email kimoto.suguru@nihon-u.ac.jp

Public contact
Name of contact person Kimoto Suguru
Organization Nihon University School of Dentistry at Matsudo
Division name Removable prosthodontics
Address sakaetyounishi 2-870-1, Matsudo-Shi, Tiba
TEL 047-368-6111
Homepage URL
Email kimoto.suguru@nihon-u.ac.jp

Sponsor
Institute Nihon University School of Dentistry at Matsudo
Institute
Department

Funding Source
Organization Nihon University School of Dentistry at Matsudo
Organization
Division
Category of Funding Organization Other
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 06 Month 07 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 10 Month 06 Day
Anticipated trial start date
2016 Year 10 Month 06 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 The targeted region to be measured were greater palatine foramen region and mental foramen region.

Management information
Registered date
2018 Year 06 Month 07 Day
Last modified on
2018 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037526

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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