UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029399 |
|---|---|
| Receipt number | 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 16:26:32 |
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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 | Obstetrics 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
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
dr.ken.inohara@gmail.com
Sponsor or person
Institute
Maruyama Home Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033594
