UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027574 |
|---|---|
| Receipt number | R000031613 |
| Scientific Title | Clinical study of socket preservation with hydroxyapatite/collagen composite material |
| Date of disclosure of the study information | 2017/05/31 |
| Last modified on | 2021/11/18 02:03:36 |
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Basic information
Public title
Clinical study of socket preservation with hydroxyapatite/collagen composite material
Acronym
socket preservation with HAp/Col
Scientific Title
Clinical study of socket preservation with hydroxyapatite/collagen composite material
Scientific Title:Acronym
socket preservation with HAp/Col
Region
| Japan |
Condition
Condition
patient who will have implant treatment after hopless tooth extraction
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to assess resorption of alveolar bone after tooth extraction
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
resorption of alveolar bone after tooth extraction
Key secondary outcomes
1. width of alveoilar bone
2. height of alveolar bone
3. infection findings
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 16 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patient who will have implant treatment after hopeless tooth extraction.
Key exclusion criteria
1. uncontrolled DM
2.steroid treatment
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Serigo |
| Middle name | |
| Last name | Ohba |
Organization
Nagasaki University
Division name
Division of Regenerative Oral Surgery
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7704
sohba@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Seigo |
| Middle name | |
| Last name | Ohba |
Organization
Nagasaki University
Division name
Division of Regenerative Oral Surgery
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7704
Homepage URL
sohba@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki Universirty
Institute
Department
Personal name
Funding Source
Organization
Nagasaki Universirty
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University
Address
1-7-1 Sakamoto, Nagaski
Tel
095-819-7704
sohba@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
| 2017 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00784-018-2705-6
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/30302606
Number of participants that the trial has enrolled
24
Results
this material can maintain the volume of the alveolar bone surrounding the tooth extraction socket.
Results date posted
| 2021 | Year | 02 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age: 25-81 yo. mean 59.3 yo.
Gender: male=8, female=16.
Participant flow
Filling HAp/Col into the extraction socket after tooth extraction.
Next week, removable of the suture.
CBCT was taken 3 months after surgery.
Subsequently, dental implant treatment was undergone as usual.
Adverse events
none
Outcome measures
HAp/Col contributed the preservation of the bone volume after tooth extraction.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Stop the exam.
Management information
Registered date
| 2017 | Year | 05 | Month | 31 | Day |
Last modified on
| 2021 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031613
