Alveolar Bone PreservationrhBMP-2NCT02714829
Clinical Study of Injectable Ceramics Bone Graft Substitute Containing rhBMP-2
A study testing Inject BMP and ExcelOS-inject in people with Alveolar Bone Preservation and Bone Graft, run by BioAlpha Inc..
Trial summary
This is a prospective, outcomes assessor-blinded, randomized study to evaluate the efficacy and safety of "Inject BMP(Injectable Ceramics Bone Graft Substitute Containing rhBMP-2)" for socket preservation after extraction of a single-rooted tooth, compared to ExcelOS-inject(Injectable Ceramics Bone Graft Substitute). Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Alveolar Bone Preservation, Bone Graft
- What is being tested?
- Inject BMP and ExcelOS-inject
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons without periodontal disease
Who cannot join
- Women who are pregnant or plan to be pregnant within study period
About this study
Official title: Clinical Study to Evaluate Efficacy and Safety of "Inject BMP(Beta-TCP Containing rhBMP-2)" for Socket Preservation After Extraction of a Single-rooted Tooth: A Randomized, Outcomes Assessor-Blinded, Multi-center, Prospective Trial.
This is a prospective, outcomes assessor-blinded, randomized study to evaluate the efficacy and safety of "Inject BMP(Injectable Ceramics Bone Graft Substitute Containing rhBMP-2)" for socket preservation after extraction of a single-rooted tooth, compared to ExcelOS-inject(Injectable Ceramics Bone Graft Substitute).
Read the detailed description
Inject BMP is Injectable Ceramics Bone Graft Substitute(ExcelOS-inject) containing rhBMP-2. Recombinant human Bone morphogenetic protein 2 (rhBMP-2) stimulates the production of bone.
- Conditions
- Alveolar Bone Preservation, Bone Graft
- Being tested
- Inject BMP, ExcelOS-inject
- Keywords
- Injectable Ceramics Bone Graft Substitute Containing rhBMP-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inject BMPDevice
Injection of ExcelOS-inject(beta-TCP) containing rhBMP-2.
ExcelOS-injectDevice
Injection of ExcelOS-inject(beta-TCP) without rhBMP-2.
| Study group | Role | What they receive |
|---|---|---|
| Inject BMP | Experimental | ExcelOS-inject containing rhBMP-2 Receives: Device: Inject BMP |
| ExcelOS-inject | Active comparator | ExcelOS-inject without rhBMP-2 Receives: Device: ExcelOS-inject |
What is being measured
The primary outcome is the main question the study is designed to answer.
compared the changed height and standard height by computed tomography.
Measured: at 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone PreservationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioAlpha Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Soon Jung Hwang, Ph.D, Principal investigator, Seoul National University Dental HospitalJong-Rak Hong, Ph.D, Principal investigator, Samsung Medical CenterHee-Kyun Oh, Ph.D, Principal investigator, Chonnam National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714829
- Sponsor's protocol ID
- ExcelOS 14-01
- Acronym
- rhBMP-2
- Status last verified
- Apr 2018
- First submitted
- 8 Mar 2016
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han JJ, Chang AR, Ahn J, Jung S, Hong J, Oh HK, Hwang SJ. Efficacy and safety of rhBMP/beta-TCP in alveolar ridge preservation: a multicenter, randomized, open-label, comparative, investigator-blinded clinical trial. Maxillofac Plast Reconstr Surg. 2021 Dec 20;43(1):42. doi: 10.1186/s40902-021-00328-0.
PubMed 34928477
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate Efficacy and Safety of "Inject BMP(Beta-TCP Containing rhBMP-2)" for Socket Preservation After Extraction of a Single-rooted Tooth: A Randomized, Outcomes Assessor-Blinded, Multi-center, Prospective Trial.
- ClinicalTrials.gov ID
- NCT02714829
- Acronym / sponsor ID
- rhBMP-2 / ExcelOS 14-01
- Conditions
- Alveolar Bone Preservation, Bone Graft
- Keywords
- Injectable Ceramics Bone Graft Substitute Containing rhBMP-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- BioAlpha Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 22 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, outcomes assessor-blinded, randomized study to evaluate the efficacy and safety of "Inject BMP(Injectable Ceramics Bone Graft Substitute Containing rhBMP-2)" for socket preservation after extraction of a single-rooted tooth, compared to ExcelOS-inject(Injectable Ceramics Bone Graft Substitute).
Detailed description
Inject BMP is Injectable Ceramics Bone Graft Substitute(ExcelOS-inject) containing rhBMP-2. Recombinant human Bone morphogenetic protein 2 (rhBMP-2) stimulates the production of bone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inject BMP | Experimental | Device: Inject BMPExcelOS-inject containing rhBMP-2 |
| ExcelOS-inject | Active comparator | Device: ExcelOS-injectExcelOS-inject without rhBMP-2 |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Persons without periodontal disease
Key exclusion criteria (1 listed)
- Women who are pregnant or plan to be pregnant within study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inject BMPInjection of ExcelOS-inject(beta-TCP) containing rhBMP-2. | Device | Inject BMP |
| ExcelOS-injectInjection of ExcelOS-inject(beta-TCP) without rhBMP-2. | Device | ExcelOS-inject |
Primary outcome
compared the changed height and standard height by computed tomography.
Time frame: at 12 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
- Derived from this study: PubMed 34928477Han JJ, Chang AR, Ahn J, Jung S, Hong J, Oh HK, Hwang SJ. Efficacy and safety of rhBMP/beta-TCP in alveolar ridge preservation: a multicenter, randomized, open-label, comparative, investigator-blinded clinical trial. Maxillofac Plast Reconstr Surg. 2021 Dec 20;43(1):42. doi: 10.1186/s40902-021-00328-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soon Jung Hwang, Ph.D principal investigator
Seoul National University Dental Hospital
Jong-Rak Hong, Ph.D principal investigator
Samsung Medical Center
Hee-Kyun Oh, Ph.D principal investigator
Chonnam National University
Questions about this trial
What is this clinical trial studying?
A study testing Inject BMP and ExcelOS-inject in people with Alveolar Bone Preservation and Bone Graft, run by BioAlpha Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compared the changed height and standard height by computed tomography. (time frame: at 12 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02714829, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2018.