UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002607 |
|---|---|
| Receipt number | R000003178 |
| Scientific Title | Clinical trial of electro-magnetic wave treatment for periapical periodontitis designed to disinfect and accelerate healing |
| Date of disclosure of the study information | 2009/11/01 |
| Last modified on | 2022/04/18 09:59:34 |
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Basic information
Public title
Clinical trial of electro-magnetic wave treatment for periapical periodontitis designed to disinfect and accelerate healing
Acronym
Clinical trial of electro-magnetic wave treatment for periapical periodontitis
Scientific Title
Clinical trial of electro-magnetic wave treatment for periapical periodontitis designed to disinfect and accelerate healing
Scientific Title:Acronym
Clinical trial of electro-magnetic wave treatment for periapical periodontitis
Region
| Japan |
Condition
Condition
Periapical periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Test for effectiveness of electro-magnetic wave treatment designed to accelerate bone and periodontal tissue healing and reduce periapical inflammation caused by infection with pathogenic bacteria invaded into root canal system
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Radiolucent area around periapical lesion
(1, 3, 6 months after treatment)
Dental CBCT (3 months after treatment)
Key secondary outcomes
Spontaneous pain, Oppressive pain, Percussion pain, Mobility, Pocket depth
(1, 3, 6 months after treatment)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Application of electro-magnetic wave into periapical lesion and root canal after complete root canal enlargement and cleaning (frequency: 500 kHz, several times, 1 second/time)
Interventions/Control_2
Interventions/Control_3
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with radiolucent area around periapical lesion
Key exclusion criteria
Patients with serious systemic illness.
Patinets inserted implantable medical electrical equipment, such as pacemaker.
Serious carious tooth or tooth with severe periodontal disease.
Patients found unfit to be as subject by dentist.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Matsuo |
Organization
The University of Tokushima Graduate School
Division name
Department of Conservative Dentistry, Institute of Health Biosciences
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima, Tokushima, 770-8504, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokushima University Hospital
Division name
Clinical Trial Center For Developmental Therapeutics
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tominaga Dental Clinic
Name of secondary funder(s)
None
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、医療法人とみなが歯科医院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2009 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2009 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2024 | 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
| 2009 | Year | 10 | Month | 08 | Day |
Last modified on
| 2022 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003178
