UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055222 |
|---|---|
| Receipt number | R000063095 |
| Scientific Title | Immediate denture fabricated intraorally |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2025/02/12 09:24:08 |
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Basic information
Public title
Immediate denture fabricated in the mouth
Acronym
Immediate denture fabricated in the mouth
Scientific Title
Immediate denture fabricated intraorally
Scientific Title:Acronym
Immediate denture fabricated intraorally
Region
| Japan |
Condition
Condition
Teeth loss
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The way of fabricating dentures in the disaster and visiting dentistry
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eating ability before and after music exercise is evaluated using following tests.
1. Bite force
2. Oral diadochokinesis
3. Repetitive saliva swallowing test
4. Tongue pressure
5. Lip closure
6. Coughing test
7. Speech test
8. Nutritional Appetite
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
Fabricated in oral cavity
Interventions/Control_2
Fabricated with impression
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Edentulous both on upper and lower jaw, or edentulous on one of the jaws.
Key exclusion criteria
Patients who doesn't have dentures
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mariko |
| Middle name | |
| Last name | Hattori |
Organization
Tokyo Medical and Dental University
Division name
Advanced Prosthodontics
Zip code
1138549
Address
Yushima 1-5-45 Bunkyo Tokyo
TEL
0358035720
sasamfp@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Hattori |
Organization
Tokyo Medical and Dental University
Division name
Advanced Prosthodontics
Zip code
1138549
Address
Yushima 1-5-45 Bunkyo Tokyo
TEL
0358035720
Homepage URL
sasamfp@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
Yushima 1-5-45 Bunkyo Tokyo
Tel
0358035720
sasamfp@tmd.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
| 2024 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The ethical review application documents have been submitted.
Management information
Registered date
| 2024 | Year | 08 | Month | 12 | Day |
Last modified on
| 2025 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063095
