UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047857
Receipt number R000054554
Scientific Title Project to improve chewing power using bitescan and gum
Date of disclosure of the study information 2022/05/25
Last modified on 2023/05/30 09:51:26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Project to improve chewing power using bitescan and gum

Acronym

Project to improve chewing power using bitescan and gum

Scientific Title

Project to improve chewing power using bitescan and gum

Scientific Title:Acronym

Project to improve chewing power using bitescan and gum

Region

Japan


Condition

Condition

Healthy person

Classification by specialty

Adult Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Verification of whether chewing ability can be improved by sharing chewing within a family unit.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Physical and oral findings
*Age, sex
*Weight, height
*Intraoral examination
Chewing frequency measurement by bitescan
*Chewing gum
*Crunchy biscuit
*Dinner
Measurement of oral function
*Chewing ability
*Tongue and lip motor function
* salivary secretion volume during masticatory stimulation
*Bite force
Questionnaire

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food Behavior,custom

Interventions/Control_1

Consume 2 pieces of gum 3 times a day equally on both sides (at least 10 minutes per time) for 4 weeks.
The whole family wears bitescan (multiple connection model: BH-BS1RB) at dinner time to measure chewing time, number of chews, and number of chews per mouthful. Measurements will be taken about 3-4 times a week, and 15 measurements will be taken.

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

6 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Families that have the custom of eating dinner together
(2) Those with normal occlusion with no abnormal findings in the morphology and function of the oral and maxillofacial system.
(3) Those who have received sufficient explanation of the purpose and content of the study, have the ability to consent, have voluntarily volunteered to participate with a good understanding, and have agreed to participate in this study in writing.

Key exclusion criteria

(1) Those who suffer from diseases affecting salivary secretion
(2) Those who have symptoms that may affect intake test foods
(3) Those who take any disease or medication that is believed to have the potential to affect the results
(4) Those who may develop allergies related to the study
(5) Those who are judged by the study director to be inappropriate to participate in this study.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Susumu
Middle name
Last name Kanno

Organization

Lotte Co., Ltd.

Division name

Central Laboratory, Kamukoto Research Department

Zip code

336-8601

Address

1-1, Numakage-3chome, Minami-ku, Saitama

TEL

048-837-0744

Email

kanno_susumu@lotte.co.jp


Public contact

Name of contact person

1st name Kenji
Middle name
Last name Osawa

Organization

Lotte Co., Ltd.

Division name

Central Laboratory, Kamukoto Research Department

Zip code

336-8601

Address

1-1, Numakage-3chome, Minami-ku, Saitama

TEL

048-837-0744

Homepage URL


Email

oosawa_kenji@lotte.co.jp


Sponsor or person

Institute

Lotte Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Lotte Co., Ltd.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Niigata University
Kyushu University
SHARP CORPORATION

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shiba Palace Clinic

Address

6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan

Tel

03-5408-1590

Email

jimukyoku@mail.souken-r.com


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

2022 Year 05 Month 25 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

48

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

2022 Year 04 Month 22 Day

Date of IRB

2022 Year 05 Month 12 Day

Anticipated trial start date

2022 Year 07 Month 23 Day

Last follow-up date

2022 Year 09 Month 12 Day

Date of closure to data entry

2022 Year 09 Month 15 Day

Date trial data considered complete

2022 Year 09 Month 18 Day

Date analysis concluded

2023 Year 01 Month 10 Day


Other

Other related information



Management information

Registered date

2022 Year 05 Month 25 Day

Last modified on

2023 Year 05 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054554


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name