UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036446 |
|---|---|
| Receipt number | R000041528 |
| Scientific Title | The evaluation of palatal augmentation prosthesis and palatal lift prosthesis on pharyngeal swallowing pressure by High-Resolution Manometry: before-after study |
| Date of disclosure of the study information | 2019/04/10 |
| Last modified on | 2025/04/14 08:48:16 |
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Basic information
Public title
The evaluation of palatal augmentation prosthesis and palatal lift prosthesis on pharyngeal swallowing pressure by High-Resolution Manometry: before-after study
Acronym
The effect of intraoral prosthesis on pharyngeal swallowing pressure
Scientific Title
The evaluation of palatal augmentation prosthesis and palatal lift prosthesis on pharyngeal swallowing pressure by High-Resolution Manometry: before-after study
Scientific Title:Acronym
The effect of intraoral prosthesis on pharyngeal swallowing pressure
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Rehabilitation medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Palatal augmentation prosthesis has been reported to increase pharyngeal pressure on the tongue base, and palatal lift prosthesis (PLP) is expected to improve pharyngeal pressure by improving nasopharyngeal closure.
However, in patients with dysphagia, the effect of intraoral prosthesis on pharyngeal swallowing has not been clarified, and few analyses of pharyngeal swallowing pressure has been made in PLP with soft lift.
In this study, we will analyze quantitatively the influence on oral -pharyngeal phase when wearing an intraoral prosthesis in patients with dysphagia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pharyngeal swallowing pressure
Key secondary outcomes
nutrition status
Patient subjectivity
swallowing function
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intraoral Prosthesis
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Agreement of taking part in this study
Patients with intraoral prosthesis for dysphagia
Dysphagia
more than level 3 of FILS(Food intake level Score)
Key exclusion criteria
Patients who judged that the HRM evaluation was inappropriate or impossible
Patients who are allergic to lidocaine
Patients who cannot use the intraoral prosthesis at meal time
Patient who use nasogastric tube for feeding during the HRM evaluation
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomohisa |
| Middle name | |
| Last name | Ohno |
Organization
Hamamatsu City Rehabilitation Hospital
Division name
Division of Dentistry
Zip code
433-8127
Address
1-6-1 Wagoukita Hamamatsu, Shizuoka, JAPAN
TEL
053-471-8331
tomohisa@zd5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Nomoto |
Organization
Hamamatsu City Rehabilitation Hospital
Division name
Division of Dentistry
Zip code
433-8127
Address
1-6-1 Wagoukita Hamamatsu, Shizuoka, JAPAN
TEL
053-471-8331
Homepage URL
n.akiko-dent@sis.seirei.or.jp
Sponsor or person
Institute
Hamamatsu City Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu City Rehabilitation Hospital
Organization
Division
Category of Funding Organization
Self funding
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 Wagoukita Hamamatsu, Shizuoka, JAPAN
Tel
053-471-8331
kamiya@sis.seirei.or.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
| 2019 | Year | 04 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 09 | Day |
Last modified on
| 2025 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041528
