UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030275 |
|---|---|
| Receipt number | R000034579 |
| Scientific Title | Establishment of prevention method for oral hypofunction in super aged society Treatment of dry mouth |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2017/12/05 18:37:19 |
* 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
Establishment of prevention method for oral hypofunction in super aged society
Treatment of dry mouth
Acronym
Treatment of dry mouth using the massage device
Scientific Title
Establishment of prevention method for oral hypofunction in super aged society
Treatment of dry mouth
Scientific Title:Acronym
Treatment of dry mouth using the massage device
Region
| Japan |
Condition
Condition
Dryness of the mouth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The object is whether massage for salivary gland using devices such as an acceleration machine and anmassaging tool is effective for improvement in oral dryness
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Measurement intraoral wet condition with measurement of salivary flaw rate
Key secondary outcomes
Evaluation of salivary secretion amount upon stimulation by Saxon test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Participants instruct to massage for salivary gland using the acceleration machine for ten seconds. This process repeat twice a week, and continue for one month.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The person who are under 65 years old and dentate completely, or the person who is over 65 years old, and has been diagnosed with oral dryness
Key exclusion criteria
1) A person who decline in cognitive function
2) A person having the disease that a salivation drop including Sjogren's syndrome is accepted
3) Those taking side effects drugs
4) The person who have a diagnosis of arrhythmia, oral cancer, arteriosclerosis
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Kanazawa |
Organization
Tokyo Medical and Dental University
Division name
Graduate school of Medical and Dental Sciences, Gerodontology and Oral Rehabilitation
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5563
m.kanazawa.gerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manabu Kanazawa |
Organization
Tokyo Medical and Dental University
Division name
Graduate school of Medical and Dental Sciences, Gerodontology and Oral Rehabilitation
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5563
Homepage URL
m.kanazawa.gerd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Lion Dental Hygiene Institute
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 05 | Day |
Last modified on
| 2017 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034579
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
