UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050818 |
|---|---|
| Receipt number | R000057911 |
| Scientific Title | Study on treatment strategies for odontogenic maxillary sinusitis. |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2023/04/11 17:55:16 |
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Basic information
Public title
Study on effective treatment method for odontogenic maxillary sinusitis
Acronym
Study of odontogenic maxillary sinusitis
Scientific Title
Study on treatment strategies for odontogenic maxillary sinusitis.
Scientific Title:Acronym
Treatment policy for odontogenic maxillary sinusitis
Region
| Japan |
Condition
Condition
Odontogenic maxillary sinusitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to provide treatment for odontogenic maxillary sinusitis in all patterns at multiple institutions, to analyze the treatment outcomes from multiple perspectives, and to create materials on more effective treatment methods with less burden.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After the target treatment is completed and data are collected, multivariate analysis will be performed on a less burdensome and more effective treatment method.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All adults diagnosed with odontogenic maxillary sinusitis and treated for it.
Key exclusion criteria
Odontogenic maxillary sinusitis caused by maxillary sinus infection after tooth extraction, foreign body, or implant infection will not be included in this study.
Target sample size
320
Research contact person
Name of lead principal investigator
| 1st name | JIRO |
| Middle name | |
| Last name | IIMURA |
Organization
Tokyo Dental College Ichikawa General Hospital
Division name
Otorhinolaryngology
Zip code
272-8513
Address
5-11-13 Sugano, Ichikawa, Chiba, Japan
TEL
0473220151
jiro.ii@icloud.com
Public contact
Name of contact person
| 1st name | JIRO |
| Middle name | |
| Last name | IIMURA |
Organization
Tokyo Dental College Ichikawa General Hospital
Division name
Otorhinolaryngology
Zip code
272-8513
Address
5-11-13 Sugano, Ichikawa, Chiba, Japan
TEL
0473220151
Homepage URL
jiro.ii@icloud.com
Sponsor or person
Institute
Department of Otorhinolaryngology, Tokyo Dental College Ichikawa General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Dental College Ichikawa General Hospital Ethics Review Committee
Address
5-11-13 Sugano, Ichikawa, Chiba, Japan
Tel
0473220151
jiro.ii@icloud.com
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
| 2023 | Year | 05 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Treatment is carried out in a conventional way. After the treatment of the subject is completed and the data are collected, the principal investigator classifies the cases from the information of the research subjects and evaluates them.
Management information
Registered date
| 2023 | Year | 04 | Month | 11 | Day |
Last modified on
| 2023 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057911
