UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029399
Receipt No. R000033594
Scientific 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.
Date of disclosure of the study information 2017/10/03
Last modified on 2018/04/04

* 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 Randomized controlled trial of the effect of professional oral care by Dental Hygienist for the patient with malignant tumor, who receives home palliative care.
Acronym Randomized controlled trial of the effect of professional oral care by Dental Hygienist for the patient with malignant tumor, who receives home palliative care.
Scientific 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.
Scientific Title:Acronym 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
1st name
Middle name
Last name Noriyoshi Maruyama
Organization Maruyama Home Clinic
Division name President
Zip code
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
1st name
Middle name
Last name Ken Inohara
Organization INOHARA Dental & Rehabilitation
Division name Vice-president
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2017 Year 03 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.