UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025100 |
|---|---|
| Receipt number | R000028760 |
| Scientific Title | Clinical research of usefulness of MTA cements.by performed under a microscope apicotomy. |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2022/12/06 16:41:00 |
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Basic information
Public title
Clinical research of usefulness of MTA cements.by performed under a microscope apicotomy.
Acronym
Clinical research of usefulness of MTA cements.by performed under a microscope apicotomy.
Scientific Title
Clinical research of usefulness of MTA cements.by performed under a microscope apicotomy.
Scientific Title:Acronym
Clinical research of usefulness of MTA cements.by performed under a microscope apicotomy.
Region
| Japan |
Condition
Condition
root cyst, periapical disease
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We performed under a microscope apicotomy using MTA cements. We examine the usefulness of MTA cements.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prognosis 12 monthes after microscope operation with MTA cements.
We determined that a successful case was a case where the normal function was restored when chewing using the concerned tooth
Key secondary outcomes
1. Change of debtalXp, panoramaXp, CT before and after operation
2. conspicuous pain, mobility, depth of probing disappearance of fistula, subjective symptoms
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Microscope operation with MTA cement
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who are 18 years old or older in income from cosentform. If patisents is under 20, We explain toleagalreoresentative.
2.Patients who have dental radicular cyst or periapical pariodontis, patients without coronal leakage. Patients who received conventional root canal treatment but were not cured.
3.Apical transportation ledge and other iatrogenic problem with persistent pathology and symptoms
4.Tooth with a latge post and crowm restoration completed, especially maxillary anterior teeth
5.Calcified canal with or without symptoms and periapical radiolucency
6.Broken instrument in apical half of the root
7.Overfilled canal with periapical radiolucency
8.Complex/compound apical curvatures that are inaccessble from an orthograde approach
9.Patient strongly desires preservation
10.In participating in this study, after having receivd sufficient explanation, patients who gained written consent by the patient's free will with sufficient understanding
Key exclusion criteria
1.Patients who have poor plaque control
2.Patients who have periodontal disease and periapical disease
3.Patients who have root fracture in operation
4.Patients who judged inappropriate as the subject by research directors
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | mitsue |
| Middle name | |
| Last name | yada |
Organization
Osaka General Medical Center
Division name
Oral & Maxillofacial Surgery
Zip code
558-8558
Address
3-1-56 Bandai-higashi Sumiyoshi-ku Osaka
TEL
06-6692-1201
mitsue@gh.opho.jp
Public contact
Name of contact person
| 1st name | mitsue |
| Middle name | |
| Last name | yada |
Organization
Osaka General Medical Center
Division name
Oral & Maxillofacial Surgery
Zip code
558-8558
Address
3-1-56 Bandai-higashi Sumiyoshi-ku Osaka
TEL
06-6692-1201
Homepage URL
mitsue@gh.opho.jp
Sponsor or person
Institute
Osaka General Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka General Medhical Center Clinical Research Review Board
Address
3-1-56 Bandai-higashi Sumiyoshi-ku,Osaka
Tel
06-6692-1201
kenkyusien@gh.opho.jp
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
大阪急性期・総合医療センター(大阪府)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 01 | 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
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 01 | Day |
Last modified on
| 2022 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028760
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
