UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032698 |
|---|---|
| Receipt number | R000037287 |
| Scientific Title | Clinical trial to assess the healing efficacy of apical periodontitis with radiolucent area using electro-magnetic apical treatment |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2018/05/24 12:08:10 |
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Basic information
Public title
Clinical trial to assess the healing efficacy of apical periodontitis with radiolucent area using electro-magnetic apical treatment
Acronym
Clinical trial to assess the healing efficacy of apical periodontitis with radiolucent area using electro-magnetic apical treatment
Scientific Title
Clinical trial to assess the healing efficacy of apical periodontitis with radiolucent area using electro-magnetic apical treatment
Scientific Title:Acronym
Clinical trial to assess the healing efficacy of apical periodontitis with radiolucent area using electro-magnetic apical treatment
Region
| Japan |
Condition
Condition
Apical periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the healing efficacy of apical periodontitis with radiolucent area using electro-magnetic apical treatment by conducting a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Periapical Index in a dental radiograph image 12 months after root canal obturation
Key secondary outcomes
1) Reduction rate of maximum diameter of bone defect in an image of cone beam computed tomography 6 months after root canal obturation
2) Periapical Index in dental radiograph images 3 and 6 months after root canal obturation
3) Presence of spontaneous pain, percussion pain, swelling, tenderness, and sinus tract 3, 6, and 12 months after root canal obturation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Application of electro-magnetic wave to a root canal and a periapical region after root canal enlargement and cleaning
Interventions/Control_2
Application of electro-magnetic wave to a root canal after root canal enlargement and cleaning
Interventions/Control_3
Ordinary root canal treatment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Permanent tooth with single root canal which needs root canal treatment due to apical lesion over 5 mm diameter with the direction of the tooth axis in image of cone beam computed tomography
Key exclusion criteria
Patients who have severe systemic diseases.
Patients who have implantable medical electric devices, such as artificial cardiac pacemakers.
Tooth with severe dental caries.
Tooth with severe periodontitis, such as Endo-Perio lesion.
Tooth with complications, internal root resorption or root fracture.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromichi Yumoto |
Organization
Tokushima University Graduate School, Institute of Biomedical Sciences
Division name
Department of Periodontology and Endodontology
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima, Tokushima
TEL
088-633-7343
yumoto@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromichi Yumoto |
Organization
Tokushima University Graduate School, Institute of Biomedical Sciences
Division name
Department of Periodontology and Endodontology
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima, Tokushima
TEL
088-633-7343
Homepage URL
yumoto@tokushima-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Dentistry, Department of Restorative Dentistry and Endodontology
Institute
Department
Personal name
Funding Source
Organization
Tokushima University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka University Graduate School of Dentistry, Department of Restorative Dentistry and Endodontology
Hokkaido University, Faculty of Dental Medicine, Department of Periodontology and Endodontology
Niigata University Graduate School of Medical and dental Sciences, Department of Oral Health Science, Division of Cariology, Operative Dentistry and Endodontic
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
徳島大学病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | 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
| 2018 | Year | 06 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | 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
| 2018 | Year | 05 | Month | 24 | Day |
Last modified on
| 2018 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037287
| 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 |
