UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Survival of vertical root fracture using with adhesive resin cement and fiber post cores
Title of the study (Brief title)	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	Tani-Ishii Nobuyuki
Organization	Graduate School of Dentistry, Kanagawa Dental Unive
Division name	Department of Pulp Biology and Endodontics,
Address	82 Inaoka, Yokosuaka
TEL	0468228856
Email	n.ishii@kdu.ac.jp

Public contact
Name of contact person	Tani-Ishii Nobuyuki
Organization	Graduate School of Dentistry, Kanagawa Dental Unive
Division name	Department of Pulp Biology and Endodontics,
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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 01 Month 01 Day
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

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