UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A research of characteristics of periodontal sensation using signal detection theory
Title of the study (Brief title)	A research of characteristics of periodontal sensation using signal detection theory
Region	Japan

Condition
Condition	Occlusal dysesthesia
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Purposes of this study is to describe the Receiver Operating Characteristic (ROC) curve of periodontal sensation in order to clarify the sensitivity of periodontal sensation using the signal detection theory and to make use of results of the present study in dental treatment. In addition, it is intended that the effect of mental or physical stress on the sensitivity of periodontal sensation is investigated by examining the possibility of plastic changes of periodontal sensation by those stress.
Basic objectives2	Others
Basic objectives -Others	AUC (Area Under Receiver Operating Characteristic Curve)
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	AUC (Area Under Receiver Operating Characteristic Curve)
Key secondary outcomes	systolic and diastolic blood pressure (mmHg), heart rate (bpm)

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Conducting one of rest for 10 minutes, 10 kgf-1minute occlusal loading (2 times), and mental arithmetic for 10 minutes at random.
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	30 years-old >=
Gender	Male and Female
Key inclusion criteria	Meeting all following items; 1) 20-30 year-old adult 2) The maxillary left first molar is vital (Even if a restoration or prosthesis already has been worn, subjects can participate in this study if they do not meet the exclusion criteria). 3) No loss of upper and lower molars except for third molars.
Key exclusion criteria	When a subjects corresponds to any of the following items, he/she is excluded from this study; 1) The maxillary left first molar is connected with adjacent tooth/teeth by restoration(s) or prosthesis (prostheses). 2) Dental caries and periodontitis which is needed to receive dental treatment in the maxillary left first molar and surrounding tissue. 3) Temporomandibular disorders. 4) Under orthodontics treatment. 5) Medical history that have been injured to craniocervical region within the past six months. 6) Medical history of psychological disorder. 7) The person whom medicine is prescribed for. 8) The person who is under the medical treatment by a medical and/or dental disease. 9) Findings suggesting nasal or dental maxillary sinusitis (any of rhinostenosis, increase in high viscous nasal discharge, pus discharge from the middle nasal meatus, feeling of gena repletion, swelling and pain on pressure of mucobuccal fold of the molar region, percussion tenderness of the upper premolars and molars).
Target sample size	20

Research contact person
Name of lead principal investigator	Shogo Minagi
Organization	Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama University
Division name	Department of Occlusal and Oral Functional Rehabilitation
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-6687
Email	minagi@md.okayama-u.ac.jp

Public contact
Name of contact person	Kazuhiro Oki
Organization	Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama University
Division name	Department of Occlusal and Oral Functional Rehabilitation
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-6687
Homepage URL
Email	kazu_z@md.okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	Japan society for the promotion science
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	2015 Year 12 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 27 Day
Anticipated trial start date	2015 Year 12 Month 16 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	2015 Year 11 Month 18 Day
Last modified on	2016 Year 11 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022931