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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043338
Receipt No. 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 2021/02/16

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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
Email 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
Email ono@dent.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

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
Email saiseiiryo@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
2021 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


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