UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randamized control traials on the effect of denture cleaning between different methods
Title of the study (Brief title)	A randamized control traials on the effect of denture cleaning between different methods
Region	Japan

Condition
Condition	edentulous
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	the effect of the denture cleaning between different methods is compared.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Patient satisfaction(At Intervention and after intervention 3,4,7 weeks)
Key secondary outcomes	cost-effectiveness(At Intervention and after intervention 3,4,7 weeks)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Instruct to dislodge denture and wash with denture brush under running water for 2 minutes after every meal and soak dentures in saline while sleeping in 3 weeks. After 1 week washout period, instruct todislodge denture and wash with denture brush under running water for 2 minutes after every meal and soak dentures in denture cleanser, Polident, while sleeping in 3 weeks.
Interventions/Control_2	Instruct todislodge denture and wash with denture brush under running water for 2 minutes after every meal and soak dentures in denture cleanser, Polident, while sleeping in 3 weeks. After 1 week washout period, instruct to dislodge denture and wash with denture brush under running water for 2 minutes after every meal and soak dentures in saline while sleeping in 3 weeks.
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	edentulous
Key exclusion criteria	Metal denture user Deteriorating general conditions
Target sample size	30

Research contact person
Name of lead principal investigator	Yusuke Sato
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	03-5803-5856
Email	y.sato.gerd@tmd.ac.jp

Public contact
Name of contact person	Yusuke Sato
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	03-5803-5856
Homepage URL
Email	y.sato.gerd@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Other
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	2016 Year 01 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 20 Day
Anticipated trial start date	2016 Year 01 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	Published
URL releasing results	https://www.sciencedirect.com/science/article/pii/S1883195818300057?via%3Dihub
Results	A combination of mechanical and chemical denture cleaning methods was more effective at cleaning dentures than the mechanical method alone. Even if denture cleaning improves denture hygiene, it may not increase patient satisfaction or OHRQoL.
Other related information

Management information
Registered date	2015 Year 11 Month 16 Day
Last modified on	2018 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022891