UMIN-CTR Clinical Trial

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

Occlusal dysesthesia

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

AUC (Area Under Receiver Operating Characteristic Curve)

Key secondary outcomes

systolic and diastolic blood pressure (mmHg), heart rate (bpm)

Study type

Interventional

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

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

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

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

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

Institute

Okayama University

Institute

Department

Personal name

Organization

Japan society for the promotion science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

12

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

11

Month

18

Day

Last modified on

2016

Year

11

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022931