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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019851
Receipt No. R000022931
Scientific Title A research of characteristics of periodontal sensation using signal detection theory
Date of disclosure of the study information 2015/12/16
Last modified on 2016/11/11

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Basic information
Public title A research of characteristics of periodontal sensation using signal detection theory
Acronym A research of characteristics of periodontal sensation using signal detection theory
Scientific Title A research of characteristics of periodontal sensation using signal detection theory
Scientific Title:Acronym 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
1st name
Middle name
Last name Shogo Minagi
Organization Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama University
Division name Department of Occlusal and Oral Functional Rehabilitation
Zip code
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
1st name
Middle name
Last name Kazuhiro Oki
Organization Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama University
Division name Department of Occlusal and Oral Functional Rehabilitation
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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
2015 Year 10 Month 27 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000022931

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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