UMIN-CTR Clinical Trial

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