UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043668 |
|---|---|
| Receipt number | R000049867 |
| Scientific Title | Comparison titanium mesh plate with bioresorbable mesh plate for vertical bone augmentation. A randomized controlled trial |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2024/02/05 13:54:12 |
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Basic information
Public title
Clinical study of the efficacy of bioresorbable mesh plate for alveolar bone augmentation
Acronym
the efficacy of bioresorbable plate for alveolar bone augmentation
Scientific Title
Comparison titanium mesh plate with bioresorbable mesh plate for vertical bone augmentation. A randomized controlled trial
Scientific Title:Acronym
Comparison titanium mesh plate with bioresorbable mesh plate for bone augmentation
Region
| Japan |
Condition
Condition
Atrophic jaw bone
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical efficacy of titanium mesh plates and bioresorbable mesh plates as membranes for vertical bone defects.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the regenerated bone volume
Key secondary outcomes
Evaluation of complication like infection or dehiscence
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
titanium mesh plate for vertical ridge augmentation
Interventions/Control_2
bioresorbable mesh plate for vertical ridge augmentation
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients who have insufficient vertical alveolar bone to place the dental implant
Key exclusion criteria
Smokers, diabetic patients, and any medically compromised patients
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Namiaki |
| Middle name | |
| Last name | Takahara |
Organization
Tokyo medical and dental University, Dental hospital
Division name
Department of maxillofacial surgery
Zip code
170-0003
Address
1-5-45, Yushima, Bunkyo-ku
TEL
0358035500
kounosur@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Marukawa |
Organization
Tokyo medical and dental University, Dental hospital
Division name
Department of maxillofacial surgery
Zip code
170-0003
Address
1-5-45, Yushima, Bunkyo-ku
TEL
0358035500
Homepage URL
eriko.m.osur@tmd.ac.jp
Sponsor or person
Institute
Tokyo medical and dental university, Dental hospital
Institute
Department
Personal name
Funding Source
Organization
Johnson & Johnson K.K
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University Certified Clinical Research Review Board
Address
1-5-45, yushima, bunkyo, Tokyo
Tel
0358034575
mkan-rinsho.adm@cmn.tmd.ac.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | 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
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2021 | Year | 03 | Month | 18 | Day |
Last modified on
| 2024 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049867
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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