UMIN-ICDS Clinical Trial

Public title

A validation study of changes in salivary volume by one-time using an oral massaging device

Acronym

A validation study of changes in salivary volume by one-time using an oral massaging device

Scientific Title

A validation study of changes in salivary volume by one-time using an oral massaging device

Scientific Title:Acronym

A validation study of changes in salivary volume by one-time using an oral massaging device

Region

Japan

Condition

Healthy male/female adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In order to verify changes in salivary volume by using an oral massager.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Salivary volume

Key secondary outcomes

Subjective questionnaire

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Utilization of the test device to the subjects for 9 min for single use.

Interventions/Control_2

Utilization of the placebo device to the subjects for 9 min for single use.

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

30

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

(1) Male/female subjects ranging in age from 30 to 79 at the moment of informed consent.
(2) Subjects with salivary secretion of not less than 2 g but no more than 6 g, at the moment of preliminary examination.
(3) Subjects who can give informed consent to take part in this study, after being provided with an explanation of the protocol detail.

Key exclusion criteria

(1) Subjects who take steadily (not less than three times a week) in the health-specific/functional (e.g., reduced coenzyme Q10-containing)/supplementary/
health foods, which might affect the test results.
(2) Subjects who have taken affecting medicines (e.g., antihistamine/
antidepressant/antihypertensive), and have any difficulty in refraining from taking them during this study.
(3) Subjects who use some kind of imitation of the test device (e.g., an electric toothbrush equipped with supersonic vibration, oral care products) habitually, and have any difficulty in refraining from using them during this study.
(4) Subjects who have been to the hospital for dental treatment within three months prior to the consent, or those who are now under the treatment (except taking a periodic dental checkup).
(5) Subjects fully realized that their gums are liable to swell up and bleed.
(6) Subjects equipped with full dentures, or being in the process of straightening their teeth.
(7) Subjects who have previous/current medical history of severe cardiac, hepatic, renal, digestive or oral diseases.
(8) Subjects who are now under other clinical tests with some kind of medicine and/or health food, or took part in those within four weeks before this study, or are going to participate in those after giving informed consent to take part in this study.
(9) Pregnant, possibly pregnant, and lactating women.
(10) Subjects having latex-related allergy.
(11) Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinions.

Target sample size

16

Name of lead principal investigator

1st name	Fumiko
Middle name
Last name	Nakamura

Organization

CPCC Company Limited

Division name

Clinical Support Department

Zip code

101-0047

Address

4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan

TEL

03-5297-3112

Email

cpcc-contact@cpcc.co.jp

Name of contact person

1st name	Masanori
Middle name
Last name	Numa

Organization

CPCC Company Limited

Division name

Clinical Planning Department

Zip code

101-0047

Address

4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan

TEL

03-5297-3112

Homepage URL

Email

cpcc-contact@cpcc.co.jp

Institute

CPCC Company Limited

Institute

Department

Personal name

Organization

Trustlex Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan

Tel

03-5297-5548

Email

IRB@cpcc.co.jp

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

2023

Year

01

Month

11

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

2021

Year

12

Month

21

Day

Date of IRB

2021

Year

12

Month

17

Day

Anticipated trial start date

2022

Year

01

Month

11

Day

Last follow-up date

2022

Year

02

Month

03

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

01

Month

05

Day

Last modified on

2022

Year

12

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052997