UMIN-CTR Clinical Trial

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
Email

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
Email

Sponsor
Institute	Tokushima University Hospital
Institute
Department

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
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、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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003178