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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027025
Receipt No. R000030983
Scientific Title The clinical evaluation of 4 META MMA TBB and mineral trioxide aggregate obturation for vertical root fracture
Date of disclosure of the study information 2017/04/17
Last modified on 2018/05/16

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Basic information
Public title The clinical evaluation of 4 META MMA TBB and mineral trioxide aggregate obturation for vertical root fracture
Acronym The clinical treatment for vertical root fracture
Scientific Title The clinical evaluation of 4 META MMA TBB and mineral trioxide aggregate obturation for vertical root fracture
Scientific Title:Acronym The clinical treatment for vertical root fracture
Region
Japan

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

Objectives
Narrative objectives1 Vertical root fractures in endodontically treated teeth are most serious complication. VRFs have a poor prognosis and usually result in tooth extraction. The purpose of this study was to evaluate the clinical outcomes of 4-META/MMA-TBB and mineral trioxide aggregate (MTA) - filled teeth with VRFs after being repaired intra-orally using microscope and ultrasonic instrument.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The clinical finding were used to evaluate the outcome were percussion pain, sinus tract, gingival swelling, and pocket depth, and the radiographic lesion. The radiographs were exposed using a standardized long-cone technique. All the patients were recalled at an interval of 3-6 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 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Firstly, Root-canal treatment was performed with rubber dam isolation under the dental microscope. All root canal was established the working length to fracture areas, the infected dentin or obturating material was eliminated using #3-5 Gates-Glidden drill (MANI Co., Utsunomiya, Japan) or Peeso reamer (MANI Co.,), and ultrasonic ENDO file (SC.4, OSADA Co., Tokyo, Japan) devices. Infected dentin was stained by 1% acid red in propylene glycol (Kuraray Co., Tokyo, Japan). The root canal cleaning was performed with 5.25% sodium hypochlorite after elimination of infected dentin.
Interventions/Control_2 MTA was delivered into the root canal by plugger or/and a MTA gun. It was condensed with the bulky side of a sterile paper point within the premeasured length to the fracture line.After the root canal obturation of MTA.
Interventions/Control_3 Clinical evaluation after tooth root adhesion was classified into three groups of maxillary premolars, maxillary molar teeth, and mandibular molar teeth and evaluated by poetry type.
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 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tani-Ishii Nobuyuki
Organization Graduate School of Dentistry, Kanagawa Dental University
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 University
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、Clinic DUBOIS,八ヶ岳歯科医院

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 17 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
 All VRF teeth exhibited clinical symptoms before treatment: 52(100%) exhibited pain on percussion, 3(5.7%) exhibited sinus tract, 4(7.7%) exhibited gingival swelling, 4(7.7%) recorded pocket depths of over 4 mm, and 39(75.0%) exhibited radiographic lesions or periodontal ligament enlargement.All intra-orally bonded VRF teeth were followed up until after 12 months treatment. All clinical symptoms were significantly improved.  The remaining teeth were showed 49 teeth (98.0%) after MTA obturation.
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
2006 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 05 Month 10 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 04 Month 17 Day
Last modified on
2018 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030983

Research Plan
Registered date File name

Research case data specifications
Registered date File name
2017/10/17 IMM-4-288.pdf

Research case data
Registered date File name
2019/05/06 IMM-4-288.pdf


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