UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026540 |
|---|---|
| Receipt number | 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 11:26:43 |
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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
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
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、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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030480
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