UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049476