UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033491 |
|---|---|
| Receipt number | R000038185 |
| Scientific Title | Effect of the removable partial dentures and the rehabilitation for masticatory and swallowing function on patients with free-end edentulism: from the viewpoint of dysphagia |
| Date of disclosure of the study information | 2018/07/24 |
| Last modified on | 2020/02/23 17:29:01 |
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Basic information
Public title
Effect of the removable partial dentures and the rehabilitation for masticatory and swallowing function on patients with free-end edentulism: from the viewpoint of dysphagia
Acronym
Effect of the removable partial dentures and the rehabilitation for masticatory and swallowing function on patients with free-end edentulism: from the viewpoint of dysphagia
Scientific Title
Effect of the removable partial dentures and the rehabilitation for masticatory and swallowing function on patients with free-end edentulism: from the viewpoint of dysphagia
Scientific Title:Acronym
Effect of the removable partial dentures and the rehabilitation for masticatory and swallowing function on patients with free-end edentulism: from the viewpoint of dysphagia
Region
| Japan |
Condition
Condition
free-end edentulism, dysphagia, masticatory dysfunction
Classification by specialty
| Oto-rhino-laryngology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the frequency of patients with dysphagia in free-end edentulism and the possibility that removable partial dentures and additional oral rehabilitation can improve the severity of dysphagia. We also carry out the same evaluation to the patients without dysphagia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. The score of oral health-related qualit y of life Japanese version (OHIP-J54)
2. The glucose elusion from gummy jelly
3. Fiberoptic endoscopic examination of swallowing
Key secondary outcomes
The rate of patients with dysphagia in free-end edentulism
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
the installation of removable partial denture
Interventions/Control_2
oral rehabilitation
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
Patients with free-end edentulism distal from first premolar either in left or right side of the upper or the lower jaw
Key exclusion criteria
Patients paticipating another study.
Patients who prefer to dental implant
or implant over denture.
Patients with congenital malformation, developmental disturbance, traumatic oral injury, inflammatory disease, or cancer.
Patients who do not agree this research.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | keiichi |
| Middle name | |
| Last name | Sasaki |
Organization
Tohoku University Graduate School of Dentistry
Division name
Advanced Prosthetic Dentistry
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Japan
TEL
022-717-8368
Keii@dent.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | makiko |
| Middle name | |
| Last name | Miyazaki |
Organization
Tohoku University Graduate School of Medicine
Division name
Otolaryngology-Head and Neck Surgery
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-7304
Homepage URL
makiko.miyazaki.r2@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Medicine
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
MHLW Certified Clinical Research Review Board, Tohoku University
Address
2-1-1 Katahira, Aoba-ku, Sendai, Miyagi, 980-8577
Tel
022-718-0461
office@nrs.hosp.tohoku.ac.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
| 2018 | Year | 07 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 24 | Day |
Last modified on
| 2020 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038185
