UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037691
Receipt number R000042985
Scientific Title Study on the effect of chewing habits and occlusal force to the basic athletic performance
Date of disclosure of the study information 2019/10/01
Last modified on 2019/11/14 15:02:53

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Basic information

Public title

Study on the effect of chewing habits and biting force to the basic athletic performance

Acronym

The effect of chewing habits and biting force to the basic athletic performance

Scientific Title

Study on the effect of chewing habits and occlusal force to the basic athletic performance

Scientific Title:Acronym

The effect of chewing habits and occlusal force to the basic athletic performance

Region

Japan


Condition

Condition

Children who are healthy but have insufficient chewing activity

Classification by specialty

Dental medicine Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

If the number of chewing times during the diet in adolescence which is decreasing tendency is supplemented with chewing training using chewing gum, how it affects the occlusal force and basic athletic performance.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase



Assessment

Primary outcomes

basic athletic performance 30 days after chewing training started

Key secondary outcomes

Occlusal force 30 days after chewing training started


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Have a gum chewing exercise training using special xylitol gum (Lotte) done for 30 days. Without designation of training time zone, free chewing without designation of chewing pace. Ask parents to record implementation records using check sheets.

Group A: 2 tablets at a time, 5 minutes per dose, once a day

Interventions/Control_2

Without gum chewing exercise training

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

12 years-old <=

Age-upper limit

15 years-old >=

Gender

Male and Female

Key inclusion criteria

Elementary school students (6th grade) and /or Junior high school studens

Students who belong to the sports club

Key exclusion criteria

Children not in oral environment or condition to chew gum

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Toshiaki
Middle name
Last name UENO

Organization

Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental Univ., Tokyo, Japan

Division name

Department of Sports Medicine/Dentistry

Zip code

113-8549

Address

1-5-45 Yushima Bunkyo-ku Tokyo Japan

TEL

03-5803--5867

Email

t.ueno.spmd@tmd.ac.jp


Public contact

Name of contact person

1st name Hiroshi
Middle name
Last name CHUREI

Organization

Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental Univ., Tokyo, Japan

Division name

Department of Sports Medicine/Dentistry

Zip code

113-8549

Address

1-5-45 Yushima Bunkyo-ku Tokyo Japan

TEL

+81358035867

Homepage URL


Email

chu.spmd@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental Univ

Institute

Department

Personal name



Funding Source

Organization

Japan Sport Association

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Meikai University
Keio University
Juntendo University
LOTTE Co., Ltd
Japan Sports Association

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Medical and Dental Univ

Address

1-5-45 Yushima Bunkyo-ku Tokyo Japan

Tel

0358035404

Email

d-hyoka.adm@tmd.ac.jp


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

2019 Year 10 Month 01 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

No longer recruiting

Date of protocol fixation

2019 Year 09 Month 30 Day

Date of IRB

2019 Year 11 Month 12 Day

Anticipated trial start date

2019 Year 10 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 08 Month 15 Day

Last modified on

2019 Year 11 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042985


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name