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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012236
Receipt No. 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

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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
Email 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
Email amemiya@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014308

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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