UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of professional oral health care for toothed elderly people who need nursing care.
Title of the study (Brief title)	Effect of professional oral health care
Region	Japan

Condition
Condition	Aspiration pneumonia
Classification by specialty	Pneumology Infectious disease Geriatrics Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy of the short-term professional oral health care for toothed elderly people who need nursing care.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change of oral condition ( Index of oral hygiene evaluation, oral microbiota ) at one month after
Key secondary outcomes	Change of oral condition ( Index of oral hygiene evaluation) at 2, 4, 6, 8 months after

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Professional oral health care group : Weekly treatment by dental hygienist for 4-weeks
Interventions/Control_2	Control group : No treatment (Self care and treatment by other nursing home staffs)
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	Toothed Elderly people over sixty four years of age Nursing care level : 1 to 5
Key exclusion criteria	Subjects who had multi-antibiotics therapy at the intervention period.
Target sample size	30

Research contact person
Name of lead principal investigator	Mitsuko Seki
Organization	Nihon University School of Dentistry
Division name	Department of Oral Health Sciences
Address	1-8-13, Kanda-Surugadai, Chiyoda-ku, Tokyo 101-8310, Japan
TEL
Email

Public contact
Name of contact person	Mitsuko Seki
Organization	Nihon University School of Dentistry
Division name	Department of Oral Health Sciences
Address	1-8-13, Kanda-Surugadai, Chiyoda-ku, Tokyo 101-8310, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Department of Oral Health Sciences Nihon University School of Dentistry
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Special Nursing Home for the Elderly "Ryusouen" Industrial Research Institute of Shizuoka Prefecture University of Shizuoka, Junior College
Name of secondary funｄer(s)	Ministry of Education, Culture, Sports, Science and Technology, Japan

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	2010 Year 02 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 02 Month 24 Day
Anticipated trial start date	2009 Year 04 Month 01 Day
Last follow-up date	2010 Year 02 Month 01 Day
Date of closure to data entry	2011 Year 01 Month 01 Day
Date trial data considered complete	2011 Year 03 Month 01 Day
Date analysis concluded	2013 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 02 Month 19 Day
Last modified on	2017 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003890