UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000041510
Receipt No. 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 (Ver. 1)

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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
Email 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
Email nanchan@nn.iij4u.or.jp

Sponsor
Institute Department of Regenerative Oral Surgery, Unit of Translational Medicine, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047383