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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000040248
Receipt No. R000045882
Scientific Title A prospective study to follow the masticatory performance of acquired anterior open bite patients
Date of disclosure of the study information 2020/04/27
Last modified on 2020/04/27

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Basic information
Public title A prospective study to follow the masticatory performance of acquired anterior open bite patients
Acronym A prospective study to follow the masticatory performance of acquired anterior open bite patients
Scientific Title A prospective study to follow the masticatory performance of acquired anterior open bite patients
Scientific Title:Acronym A prospective study to follow the masticatory performance of acquired anterior open bite patients
Region
Japan

Condition
Condition Acquired anterior open bite patients
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To follow up acquired anterior open bite patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in masticatory performance
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
18 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Acquired anterior open bite patients.
The progress of anterior open bite has stopped.
Key exclusion criteria Patients
(1)with two or more missing molars except for the third molar
(2)who use removable dentures
(3)undergoing medical treatment, orthodontic treatment, and dental treatment
(4)with physical or mental disorders
(5)with pain that interferes with daily life
(6)who had an anterior open bite before adulthood
(7)with autoimmune disease.
Target sample size 34

Research contact person
Name of lead principal investigator
1st name Yoshiaki
Middle name
Last name Arai
Organization Niigata University Medical and Dental Hospital
Division name Temporomandibular Joint Disorder and Implant Clinic
Zip code 951-8520
Address 754, Asahimachi-1, Chuou-ku, Niigata city, Niigata
TEL 0252272975
Email ara@dent.niigata-u.ac.jp

Public contact
Name of contact person
1st name Yoshiaki
Middle name
Last name Arai
Organization Niigata University Medical and Dental Hospital
Division name Temporomandibular Joint Disorder and Implant Clinic
Zip code 951-8520
Address 754, Asahimachi-1, Chuou-ku, Niigata city, Niigata
TEL 0252272975
Homepage URL
Email ara@dent.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

Funding Source
Organization Self-funding
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 Institutiona Review Board of the Niigata University
Address 2-5274 Gakkomachi, Chuo-ku, Niigata
Tel 0252272975
Email ara@dent.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
2020 Year 04 Month 27 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 Suspended
Date of protocol fixation
2019 Year 04 Month 08 Day
Date of IRB
2020 Year 05 Month 25 Day
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A prospective study

Management information
Registered date
2020 Year 04 Month 27 Day
Last modified on
2020 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045882

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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