UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041510 |
|---|---|
| Receipt number | R000047383 |
| Scientific Title | Clinical application of autogenous demineralized dentin matrix prepared immediately after extraction for alveolar bone regeneration |
| Date of disclosure of the study information | 2020/08/21 |
| Last modified on | 2020/08/21 19:32:26 |
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Basic information
Public title
Clinical application of autogenous demineralized dentin matrix prepared immediately after extraction for alveolar bone regeneration
Acronym
Clinical application of ADDM after extraction for alveolar bone regeneration
Scientific Title
Clinical application of autogenous demineralized dentin matrix prepared immediately after extraction for alveolar bone regeneration
Scientific Title:Acronym
Clinical application of ADDM after extraction for alveolar bone regeneration
Region
| Japan |
Condition
Condition
Lost of alveolar bone
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to estimate the efficacy of the DDM as biomaterial for bone regeneration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After implantation of the ADDM at 4, 8, 16, and/or 24 weeks, we evaluated the tissue with histology and radiology.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
autogenous demineralized dentin matrix
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects were patients who required bone augmentation for dental implant treatment including 1) socket preservation, 2) maxillary sinus floor augmentation, and 3) alveolar ridge augmentation during dental implant placement simultaneous with tooth extraction.
Key exclusion criteria
a) Patients who had undergone radiation therapy in the oral and maxillofacial region,b) Patients who had undergone other bone grafting in the surgical area, and who had the history of maxillary sinus disease or symptoms were excluded.
c) Patients who had uncontrolled systemic disease were also excluded.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tokutaro |
| Middle name | |
| Last name | Minamizato |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Regenerative Oral Surgery, Unit of Translational Medicine
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki-city, Nagasaki, Japan
TEL
095-819-7704
nanchan@nn.iij4u.or.jp
Public contact
Name of contact person
| 1st name | Tokutaro |
| Middle name | |
| Last name | Minamizato |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Regenerative Oral Surgery, Unit of Translational Medicine
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki-city, Nagasaki, Japan
TEL
095-819-7704
Homepage URL
nanchan@nn.iij4u.or.jp
Sponsor or person
Institute
Department of Regenerative Oral Surgery, Unit of Translational Medicine, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Regenerative Oral Surgery, Unit of Translational Medicine, Nagasaki University Graduate School of Biomedical Sciences
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
Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki-city, Nagasaki, Japan
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.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
| 2020 | Year | 08 | Month | 21 | Day |
Related information
URL releasing protocol
https://www.ijoms.com/article/S0901-5027(17)31571-0/fulltext
Publication of results
Published
Result
URL related to results and publications
https://www.ijoms.com/article/S0901-5027(17)31571-0/fulltext
Number of participants that the trial has enrolled
40
Results
The clinical application of APDDM prepared immediately after tooth extraction to bone augmentation, taking advantage of the relatively short preparation time due to partial demineralization. APDDM, as introduced in this study, is an efficient, safe, and reasonable bone substitute. Consequently, this material has the potential to become one of the options as a bone substitute in implant dentistry.
Results date posted
| 2020 | Year | 08 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
As Protocol.
Participant flow
As Protocol.
Adverse events
Nothing Particular.
Outcome measures
As Protocol.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | 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
| 2020 | Year | 08 | Month | 21 | Day |
Last modified on
| 2020 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047383
