UMIN-CTR Clinical Trial

Public title

A study of the effect of mental arithmetic stress on periodontal sensation and tactile sensation on cheek.

Acronym

A study of the effect of mental arithmetic stress on periodontal sensation and tactile sensation on cheek.

Scientific Title

A study of the effect of mental arithmetic stress on periodontal sensation and tactile sensation on cheek.

Scientific Title:Acronym

A study of the effect of mental arithmetic stress on periodontal sensation and tactile sensation on cheek.

Region

Japan

Condition

Occlusal dysesthesia

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine whether mental arithmetic stress specifically has an influence on the occlusal sensation, this study investigates the changes of sense threshold of the periodontal sensation and tactile sensation on the cheek before and after mental arithmetic stress.

Basic objectives2

Others

Basic objectives -Others

Thresholds of periodontal sensation (mN) and tactile sensation on cheek (gf) before and after mental arithmetic stress

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Thresholds of periodontal sensation (mN) and tactile sensation on cheek (gf) before and after mental arithmetic stress

Key secondary outcomes

No assumption

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Mental arithmetic for 10 minutes

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

31

years-old

>

Gender

Male and Female

Key inclusion criteria

Meeting all following items;
1) 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).
2) The left cheek skin does not have an injury or a scar in an ocular inspection.
3) 20-30 year-old adult

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 not vital or missing.
2) The maxillary left first molar is connected with adjacent tooth/teeth by restoration(s) or prosthesis (prostheses).
3) Occlusal contacts is missing against the maxillary left first molar by the opposing teeth. (When occlusal contacts were recovered by a prosthesis in the opposing teeth, this condition can be acceptable.)
4) Dental caries and periodontitis which is needed to receive dental treatment in the maxillary left first molar and surrounding tissue.
5) Temporomandibular disorders
6) Under orthodontics treatment
7) Medical history that have been injured to craniocervical region within the past six months.
8) Medical history of psychological disorder.
9) The person whom medicine is prescribed for.
10) The person who is under the medical treatment by a medical and/or dental disease.

Target sample size

80

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

Okayama University

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

11

Month

12

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

08

Month

18

Day

Date of IRB

Anticipated trial start date

2015

Year

08

Month

29

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This research conducted as one of workshop of the 9th Stomatognathic Function Seminar held on August 29th, 2015.
Participants of measuring absolute threshold of periodontal sensation were 12 volunteers (6 male and 6 female), and those of measuring differential threshold of cheek were 16 volunteers (11 male and 5 female).
There was no significant differences between the absolute threshold of periodontal sensation before the intervention (mean 0.866, SD 0.355 (N)) and after (mean 0.978, SD 0.478 (N)) (t = -0.847, df = 11, p = 0.41).
To be similar to the result of the periodontal sensation, there was no significant differences between the differential threshold of cheek before the intervention (mean 0.71, SD0.33 (gf)) and after (mean 0.67, SD0.31 (gf)) (t = 0.432, df = 15, p = 0.67).

Due to the discussion about the methods and results, it was clarified that mental arithmetic as the intervention was needed to be objectively examined.
In consideration of above mentioned background, changes of this research protocol as follows were applied to Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Comittee and approved on December 15th, 2015;
1) monitoring systolic and diastolic blood pressure and heart rate before and after mental arithmetics
2) addition of 40 subjects in order to conduct the changed protocol (participant number changed 40 to 80)

Registered date

2015

Year

11

Month

12

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=R000022817