UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037447 |
|---|---|
| Receipt number | R000042683 |
| Scientific Title | Evaluation of alveolar bone using optical coherence tomography (OCT) |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2020/07/22 12:03:17 |
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Basic information
Public title
Evaluation of alveolar bone using optical coherence tomography (OCT)
Acronym
Evaluation of alveolar bone using optical coherence tomography (OCT)
Scientific Title
Evaluation of alveolar bone using optical coherence tomography (OCT)
Scientific Title:Acronym
Evaluation of alveolar bone using optical coherence tomography (OCT)
Region
| Japan |
Condition
Condition
periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether bone defect can be evaluated by OCT imaging
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OCT image of periodontal surgery planned site, shape of bone defect during periodontal surgery
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
Patients scheduled for periodontal surgery
Key exclusion criteria
Patients with infection such as HBV, HCV, HIV
Taking medications that affect mucosal thickness
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Aoki |
Organization
Graduate School of Medical and Dental Science, Tokyo Medical and Dental University
Division name
Department of Periodontology
Zip code
113-8549
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
0358035488
aoperi@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Aoki |
Organization
Graduate School of Medical and Dental Science, Tokyo Medical and Dental University
Division name
Department of Periodontology
Zip code
113-8549
Address
1-5-45 Yushima Bunkyo-ku, Tokyo
TEL
0358035488
Homepage URL
aoperi@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
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 Medical and Dental University
Address
1-5-45 Yushima Bunkyo-ku, Tokyo
Tel
0358035404
d-hyoka.adm@tmd.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
| 2019 | Year | 09 | 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
| 2019 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | 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
OCT images and clinical information acquired for treatment are collected. OCT imaging, clinical examination, and intraoral photography are performed before surgery and after 6 months. Intraoral photography is also performed after debridement during periodontal surgery.
Management information
Registered date
| 2019 | Year | 07 | Month | 22 | Day |
Last modified on
| 2020 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042683
