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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032698
Receipt No. 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

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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
Email 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
Email yumoto@tokushima-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Dentistry, Department of Restorative Dentistry and Endodontology
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037287

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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