UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027025 |
|---|---|
| Receipt number | 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 17:09:25 |
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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
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
n.ishii@kdu.ac.jp
Sponsor or person
Institute
Department of Pulp Biology and Endodontics,
Graduate School of Dentistry, Kanagawa Dental University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
