UMIN-CTR Clinical Trial

Basic information
Public title	The effect of dentures on swallowing function -A prospective intervention study-
Acronym	The effect of dentures on swallowing function
Scientific Title	The effect of dentures on swallowing function -A prospective intervention study-
Scientific Title:Acronym	The effect of dentures on swallowing function
Region	Japan

Condition
Condition	swallowing disorder
Classification by specialty	Rehabilitation medicine Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect on pharyngeal swallowing function of patients with dysphagia between with and without dentures.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Normalized Residue Ratio Scale: NRRS
Key secondary outcomes	Oral transit time Pharyngeal transit time Penetration Aspiration Scale: PAS

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	presence of dentures during videofluoroscopic examination
Interventions/Control_2	absence of dentures during videofluoroscopic examination
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	1 years-old <=
Age-upper limit	120 years-old >
Gender	Male and Female
Key inclusion criteria	patients who need speech therapy patients who need videofluoroscopic examination patients who use dentures patients who can agree to participate in this research
Key exclusion criteria	patients with dementia patients with dysphagia by local pharyngeal causes
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Tomohisa Middle name Ohno Last name Ohno
Organization	Hamamatsu City Rehabilitation Hospital
Division name	Department of Dentistry
Zip code	433-8511
Address	1-6-1, Wagokita, Naka-ku, Hamamatsu-city, Shizuoka, Japan
TEL	+81534718331
Email	tomohisa@zd5.so-net.ne.jp

Public contact
Name of contact person	1st name Ohno Middle name Last name Tomohisa
Organization	Hamamatsu City Rehabilitation Hospital
Division name	Department of Dentistry
Zip code	433-8511
Address	1-6-1, Wagokita, Naka-ku, Hamamatsu-city, Shizuoka, Japan
TEL	+81534718331
Homepage URL
Email	tomohisa@zd5.so-net.ne.jp

Sponsor
Institute	Hamamatsu City Rehabilitation Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hamamatsu City Rehabilitation Hospital
Address	1-6-1, Wagokita, Naka-ku, Hamamatsu-city, Shizuoka, Japan
Tel	+81534718331
Email	tomohisa@zd5.so-net.ne.jp

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	2020 Year 06 Month 20 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	2020 Year 06 Month 17 Day
Date of IRB	2020 Year 06 Month 29 Day
Anticipated trial start date	2020 Year 06 Month 20 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 06 Month 18 Day
Date trial data considered complete	2021 Year 06 Month 18 Day
Date analysis concluded	2021 Year 06 Month 18 Day

Other
Other related information

Management information
Registered date	2020 Year 06 Month 17 Day
Last modified on	2021 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046584