UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Establishment of prevention method for oral hypofunction in super aged society Treatment of dry mouth
Title of the study (Brief title)	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	Manabu Kanazawa
Organization	Tokyo Medical and Dental University
Division name	Graduate school of Medical and Dental Sciences, Gerodontology and Oral Rehabilitation
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5563
Email	m.kanazawa.gerd@tmd.ac.jp

Public contact
Name of contact person	Manabu Kanazawa
Organization	Tokyo Medical and Dental University
Division name	Graduate school of Medical and Dental Sciences, Gerodontology and Oral Rehabilitation
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5563
Homepage URL
Email	m.kanazawa.gerd@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034579