UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046540 |
|---|---|
| Receipt number | R000052997 |
| Scientific Title | A validation study of changes in salivary volume by one-time using an oral massaging device |
| Date of disclosure of the study information | 2023/01/11 |
| Last modified on | 2022/12/28 16:34:35 |
* 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
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
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
Primary outcomes
Salivary volume
Key secondary outcomes
Subjective questionnaire
Base
Study type
Interventional
Study design
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
Intervention
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
Eligibility
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
Research contact person
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
cpcc-contact@cpcc.co.jp
Public contact
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
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Trustlex Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
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
IRB@cpcc.co.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
| 2023 | Year | 01 | Month | 11 | 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
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
Other related information
Management 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/ctr_e/ctr_view.cgi?recptno=R000052997
