UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032955
Receipt No. R000037358
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 2018/06/15
Last modified on 2019/06/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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, or 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 -but assessor(s) are 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Permanent teeth which need root canal treatment due to apical lesions over 3 mm in diameter and over 2 mm with the direction of the teeth axes localized single root in images of cone beam computed tomography
Key exclusion criteria Patients who have severe systemic diseases
Patients who have implantable medical devices such as artificial cardiac pacemakers
Teeth with severe caries
Teeth with severe periodontitis (Endo-perio region)
Teeth with complications, internal root resorptions, root fractures
Target sample size 24

Research contact person
Name of lead principal investigator
1st name MIkako
Middle name
Last name Hayashi
Organization Osaka University Graduate School of Dentistry
Division name Department of Restorative Dentistry and Endodontology
Zip code 565-0871
Address 1-8 Yamadaoka, Suita
TEL 06-6879-2926
Email mikarin@dent.osaka-u.ac.jp

Public contact
Name of contact person
1st name Hazuki
Middle name
Last name Maezono
Organization Osaka University Graduate School of Dentistry
Division name Department of Restorative Dentistry and Endodontology
Zip code 565-0871
Address 1-8 Yamadaoka, Suita
TEL 06-6879-2927
Homepage URL
Email maezono@dent.osaka-u.ac.jp

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

Funding Source
Organization Osaka University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Division of Cariolology, Operative Dentistry and Endodontics, Department of Oral Health Science, Niigata University Graduate School of Medical and Dental Sciences
Department of Periodontology and Endodontology, Institute of Biomedical Sciences, Tokushima University Graduate School
Name of secondary funder(s)

IRB Contact (For public release)
Organization the institutional review board and ethics committee of Osaka University Dental Hospital
Address 1-8, Yamadaoka, Suita, Osaka
Tel 06-6879-5111
Email si-soumu-syomu@office.osaka-u.ac.jp

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 大阪大学歯学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 15 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 Open public recruiting
Date of protocol fixation
2018 Year 04 Month 16 Day
Date of IRB
2018 Year 02 Month 22 Day
Anticipated trial start date
2018 Year 06 Month 15 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 12 Day
Last modified on
2019 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037358

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.