UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012236 |
|---|---|
| Receipt number | R000014308 |
| Scientific Title | Periapical surgery using dental microscope based on diagnosis with CBCT |
| Date of disclosure of the study information | 2014/01/14 |
| Last modified on | 2014/05/07 19:16:20 |
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Basic information
Public title
Periapical surgery using dental microscope based on diagnosis with CBCT
Acronym
Periapical surgery using dental microscope based on diagnosis with CBCT
Scientific Title
Periapical surgery using dental microscope based on diagnosis with CBCT
Scientific Title:Acronym
Periapical surgery using dental microscope based on diagnosis with CBCT
Region
| Japan |
Condition
Condition
The patient who was infected with intractable apical periodontitis
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We improve a treatment result of intractable apical periodontitis by getting three-dimensional preoperative image views using CBCT, and using a microscope by carrying out a less-invasive and a minute apicoectomy operation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We improve a treatment result of intractable apical periodontitis by getting three-dimensional preoperative image views using CBCT, and using a microscope by carrying out a less-invasive and a minute apicoectomy operation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The patient who was infected with intractable apical periodontitis
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient who was infected with intractable apical periodontitis and that obtained agreement of research cooperation.
Key exclusion criteria
Intraoral malignant tumor disease patients.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Amemiya |
Organization
Kyoto Prefectural University of Medicine
Division name
Dental Medicine, Graduate School of Medical Science
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5641
amemiya@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Amemiya |
Organization
Kyoto Prefectural University of Medicine
Division name
Dental Medicine, Graduate School of Medical Science
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5641
Homepage URL
amemiya@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2014 | Year | 01 | Month | 14 | 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
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 07 | Day |
Last modified on
| 2014 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014308
