UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043338 |
|---|---|
| Receipt number | R000049476 |
| Scientific Title | Study on masticatory function of patients with defective prosthesis |
| Date of disclosure of the study information | 2021/02/17 |
| Last modified on | 2022/02/17 12:50:25 |
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Basic information
Public title
Study on masticatory function of patients with defective prosthesis
Acronym
Masticatory function of defective prosthetic patients
Scientific Title
Study on masticatory function of patients with defective prosthesis
Scientific Title:Acronym
Masticatory function of defective prosthetic patients
Region
| Japan |
Condition
Condition
masticatory disturbance
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
More detailed elucidation of factors affecting masticatory function
Basic objectives2
Others
Basic objectives -Others
Building a database of defective prosthetic cases
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mastication performance
Occlusal contact test
Occlusal Force Test
Oral and Denture Examination
Food Questionnaire
Denture Questionnaire
OHIP-14
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 30 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Those who visited the Removable Prosthodontic Clinic or General Dentistry and Clinical Education Unit at Niigata University Medical & Dental Hospital and routinely wore maxillary and/or mandibular dentures.
2) Those who give us an informed consent to participate in the study after face-to-face explanation by investigators.
Key exclusion criteria
1) Those who do not clear the criteria stated above.
2) Those who are inadequate persons as subjects, a primary investigator judges.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ono |
Organization
Niigata University
Division name
Graduate school of medical and dental sciences
Zip code
951-8514
Address
5274 2-Bancho, Gakkocho-dori, Niigata
TEL
025-227-2891
ono@dent.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Ono |
Organization
Niigata University
Division name
Graduate school of medical and dental sciences
Zip code
951-8514
Address
5274 2-Bancho, Gakkocho-dori, Niigata
TEL
025-227-2891
Homepage URL
ono@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
MECSST
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Committee for Research Involving Human Subjects
Address
5274 1-Bancho, Gakkocho-dori, Niigata
Tel
025-227-2436
ethics@adm.niigata-u.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
| 2021 | Year | 02 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data of masticatory function test before and after treatment of patients who have undergone defect prosthodontic treatment with dentures, etc. in the Department of Denture Clinic, General Medical Department / Clinical Training Department, Niigata University Medical and Dental General Hospital, and the preoperative examination Observe changes in masticatory efficiency before and after surgery, which is an objective index of masticatory function, based on intraoral findings recorded based on disease type classification and other data on prosthetic treatment described in medical records.
Management information
Registered date
| 2021 | Year | 02 | Month | 16 | Day |
Last modified on
| 2022 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049476
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
