UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040799 |
|---|---|
| Receipt number | R000046584 |
| Scientific Title | The effect of dentures on swallowing function -A prospective intervention study- |
| Date of disclosure of the study information | 2020/06/20 |
| Last modified on | 2021/06/18 09:08:12 |
* 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
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
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
tomohisa@zd5.so-net.ne.jp
Sponsor or person
Institute
Hamamatsu City Rehabilitation Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046584
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
