UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled trial of the effect of professional oral care by Dental Hygienist for the patient with malignant tumor, who receives home palliative care.
Title of the study (Brief title)	Randomized controlled trial of the effect of professional oral care by Dental Hygienist for the patient with malignant tumor, who receives home palliative care.
Region	Japan

Condition
Condition	Patients with malignant tumor, receiving home palliative care.
Classification by specialty	Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine Pneumology Endocrinology and Metabolism Hematology and clinical oncology Nephrology Neurology Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery Endocrine surgery Breast surgery Obsterics and gynecology Dermatology Oto-rhino-laryngology Urology Oral surgery Neurosurgery Dental medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Randomized controlled trial of the effect of professional oral care by dental hygienist for the patient with malignant tumor,who receives home palliative care.This trial is compared with the case of general oral care by medical and nursing care workers.The clinical benefit will be indicated by the frequency of oral candidiasis,dryness of the mouse,halitosis and a questionnaire survey from their family after the patient pass away.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1)The frequency and the period of oral candidiasis 2)The level of dryness of the mouse measured by an oral moisture checker (MucusTM ). 3)The level of halitosis 4)A questionnaire survey from their family after the patient pass away. 5)Safety:the rate of incidence of oral hemorrhage
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Interventions:48 Professional oral care by dental hygienist for the patient with malignant tumor, who receive home palliative care.
Interventions/Control_2	Control_1):48 General oral care by medical and nursing care workers for the patient with malignant tumor, who receive home palliative care.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(a) Over 20 years old when obtaining informed consent. (b) Consciousness level is over 0 or I-1 in JCS when obtaining informed consent. (c)The patient diagnosed as malignant tumor at terminal stage and will receive home palliative care by Maruyama Home Clinic. (d) The patient whose prognosis will be more than two weeks at initial diagnosis by the physician in charge. (e) The patient who will be able to receive visiting care more than three times before he/she passes away. (f) The care of no need for dental treatment or dental care except denture repair, denture adjustment when starting this trial.
Key exclusion criteria	(a) The patient who has already received professional oral care by dentists or dental hygienists before this trial starts. (b) His/her home doctor recognizes that it is not suitable for him to join this trial.
Target sample size	96

Research contact person
Name of lead principal investigator	Noriyoshi Maruyama
Organization	Maruyama Home Clinic
Division name	President
Address	New Kamome Mansion 102 6-27-26,Minamizao, Fukuyama-city Hiroshima, JAPAN
TEL	+81-84-943-7307
Email	n.maruyama@fmed.jp

Public contact
Name of contact person	Ken Inohara
Organization	INOHARA Dental & Rehabilitation
Division name	Vice-president
Address	5-28-15,Tajime-cho Fukuyama-city, Hiroshima, JAPAN
TEL	+81-84-959-4601
Homepage URL
Email	dr.ken.inohara@gmail.com

Sponsor
Institute	Maruyama Home Clinic
Institute
Department

Funding Source
Organization	The Yuumi Memorial Foundation of Home Health Care, Public Interest Incorporated Foundation
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	2017 Year 10 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 01 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
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 10 Month 03 Day
Last modified on	2018 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033594