UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040248 |
|---|---|
| Receipt number | 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 | 2024/01/16 13:32:57 |
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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
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
ara@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
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
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
Enrolling by invitation
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
| 2025 | 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
| 2024 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045882
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
