UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial to assess the healing efficacy of apical periodontitis with radiolucent area using electro-magnetic apical treatment
Title of the study (Brief title)	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	Hiromichi Yumoto
Organization	Tokushima University Graduate School, Institute of Biomedical Sciences
Division name	Department of Periodontology and Endodontology
Address	3-18-15 Kuramoto-cho, Tokushima, Tokushima
TEL	088-633-7343
Email	yumoto@tokushima-u.ac.jp

Public contact
Name of contact person	Hiromichi Yumoto
Organization	Tokushima University Graduate School, Institute of Biomedical Sciences
Division name	Department of Periodontology and Endodontology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 06 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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