UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032955 |
|---|---|
| Receipt number | 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 | 2023/06/16 14:44:28 |
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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, 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 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
hayashi.mikako.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
maezono.hazuki.dent@osaka-u.ac.jp
Sponsor or person
Institute
Department of Restorative Dentistry and Endodontology, Osaka University Graduate School of Dentistry
Institute
Department
Personal name
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
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
34
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
| 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
| 2023 | Year | 02 | Month | 21 | 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
| 2023 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037358
