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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026540
Receipt No. R000030480
Scientific Title Survival of vertical root fracture using with adhesive resin cement and fiber post cores
Date of disclosure of the study information 2017/03/14
Last modified on 2017/03/14

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Basic information
Public title Survival of vertical root fracture using with adhesive resin cement and fiber post cores
Acronym Treatment of vertical root fracture
Scientific Title Survival of vertical root fracture using with adhesive resin cement and fiber post cores
Scientific Title:Acronym Treatment of vertical root fracture
Region
Japan

Condition
Condition root fracture tooth
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was evaluated the postoperative clinical outcome of root canal adhesion therapy with root canal using 4-META / MMA-TBB and MTA cement, so that the significance of establishing reliable treatment for root fracture is significant is there.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The clinical findings used to evaluate the outcome were pain on percussion, sinus tracts, gingival swelling, and increased pocket depth, and the presence of radiographic lesions. The radiographs were exposed using a standardized long-cone technique. All patients were recalled at intervals of 12 months for maintenance
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Single fiber post group (93 teeth).
Fiber posts were selected according to the configuration of the root canals.
The composite resin core materials with single fiber posts showed higher bending strength than that with only one fiber post core
Interventions/Control_2 Multiple fiber post group (208 teeth)
Fiber posts were selected according to the configuration of the root canals.
The composite resin core materials with multiple fiber posts showed higher bending strength than that with only one fiber post core.
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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria A case of root canal adhering method for root canal fracture and root canal perforation introduced at Kanagawa Dental College Hospital, Yatsugatake dentistry, which was introduced as an endodontic refractory case, was applied.
Key exclusion criteria 1) Those who are undergoing treatment due to infection with hemophilia, hepatitis, HIV, etc. and those who are at risk of treatment due to high blood pressure, diabetes etc.
2) Pregnant women or lactating women
3) Person who has participated in the trial within 12 weeks before the start of this procedure
4) Person who judged that the dental
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tani-Ishii Nobuyuki
Organization Graduate School of Dentistry, Kanagawa Dental Unive
Division name Department of Pulp Biology and Endodontics,
Zip code
Address 82 Inaoka, Yokosuaka
TEL 0468228856
Email n.ishii@kdu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tani-Ishii Nobuyuki
Organization Graduate School of Dentistry, Kanagawa Dental Unive
Division name Department of Pulp Biology and Endodontics,
Zip code
Address 82 Inaoka, Yokosuaka
TEL 0468228856
Homepage URL
Email n.ishii@kdu.ac.jp

Sponsor
Institute Department of Pulp Biology and Endodontics,
Graduate School of Dentistry, Kanagawa Dental University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) Graduate School of Dentistry, Kanagawa Dental University

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 神奈川歯科大学附属病院、八ヶ岳歯科医院

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 14 Day

Related information
URL releasing protocol http://ci.nii.ac.jp/naid/10027692304
Publication of results Partially published

Result
URL related to results and publications http://ci.nii.ac.jp/naid/10027692304
Number of participants that the trial has enrolled
Results
As a result of periodic examination (292 months) of 292 patients who underwent the root canal adhesion method of the root canal, the recall period of the Single group (n = 90) was 69.4 + 22.9 months on average, the Multiple group (n = 203) Was 48.8 + 22.9 months. The 5-year survival rate (Kaplan-Meier) of 292 cases was 90.9% in the Single group and 95.4% in the Multiple group, the 7-year survival rate (Kaplan-Meier) was 88.9% in the Single group and 87.8% in the Multiple group. 
From the above results, it was shown that root canal root adhesion method for vertical root root fracture tooth using 4-META / MMA-TBB resin and fiber post core combined is an effective treatment for avoiding tooth extraction.
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
2006 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 04 Month 01 Day
Last follow-up date
2020 Year 12 Month 25 Day
Date of closure to data entry
2021 Year 01 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 03 Month 14 Day
Last modified on
2017 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030480

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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