Regeneration of Alveolar Tissue After Maxillary Sinus Floor AugmentationPhase 3NCT01634308
Efficacy and Safety of Bongros-BMP Compared to Bio-oss for Regeneration of Alveolar Bone Tissue After Maxillary Sinus Floor Augmentation
A Phase 3 study testing Novosis(bongros/BMP-2) and Bio-oss in people with Regeneration of Alveolar Tissue After Maxillary Sinus Floor Augmentation, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of this Clinical study was to evaluate the Efficacy and Safety of bongros-BMP compared to Bio-oss for Regeneration of alveolar bone tissue after Maxillary sinus floor augmentation. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Regeneration of Alveolar Tissue After Maxillary Sinus Floor Augmentation
- What is being tested?
- Novosis(bongros/BMP-2) and Bio-oss
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2010to Jun 2012
- Phase
- Phase 3
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dept. of Oral and Maxillofacial Surgery and School of Dentistry, Seoul National University
Seoul
About this study
The purpose of this Clinical study was to evaluate the Efficacy and Safety of bongros-BMP compared to Bio-oss for Regeneration of alveolar bone tissue after Maxillary sinus floor augmentation.
- Being tested
- Novosis(bongros/BMP-2), Bio-oss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novosis(bongros/BMP-2)Drug
Bio-ossDrug
| Study group | Role | What they receive |
|---|---|---|
| Novosis(bongros/BMP-2) | Experimental | Not described Receives: Drug: Novosis(bongros/BMP-2) |
| Bio-oss | Active comparator | Not described Receives: Drug: Bio-oss |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJun 2010
- Primary completionJun 2012
- Study completionJun 2012
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 Regeneration of Alveolar Tissue After Maxillary Sinus Floor AugmentationStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- 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 3
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bio-alpha Co. LTD.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634308
- Sponsor's protocol ID
- BA05-CP01
- Status last verified
- Jul 2012
- First submitted
- 3 Jul 2012
- Last updated
- 13 Jul 2012
- Results posted
- No
Publications
Kim HJ, Chung JH, Shin SY, Shin SI, Kye SB, Kim NK, Kwon TG, Paeng JY, Kim JW, Oh OH, Kook MS, Yang HJ, Hwang SJ. Efficacy of rhBMP-2/Hydroxyapatite on Sinus Floor Augmentation: A Multicenter, Randomized Controlled Clinical Trial. J Dent Res. 2015 Sep;94(9 Suppl):158S-65S. doi: 10.1177/0022034515594573. Epub 2015 Jul 16.
PubMed 26185033
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Bongros-BMP Compared to Bio-oss for Regeneration of Alveolar Bone Tissue After Maxillary Sinus Floor Augmentation
- ClinicalTrials.gov ID
- NCT01634308
- Acronym / sponsor ID
- BA05-CP01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Collaborators
- Bio-alpha Co. LTD.
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 6 Jul 2012 (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.
The purpose of this Clinical study was to evaluate the Efficacy and Safety of bongros-BMP compared to Bio-oss for Regeneration of alveolar bone tissue after Maxillary sinus floor augmentation.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novosis(bongros/BMP-2) | Experimental | Drug: Novosis(bongros/BMP-2) |
| Bio-oss | Active comparator | Drug: Bio-oss |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Novosis(bongros/BMP-2) | Drug | Novosis(bongros/BMP-2) |
| Bio-oss | Drug | Bio-oss |
Primary outcome
Not reported in the source record.
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 13 Jul 2012.
- Derived from this study: PubMed 26185033Kim HJ, Chung JH, Shin SY, Shin SI, Kye SB, Kim NK, Kwon TG, Paeng JY, Kim JW, Oh OH, Kook MS, Yang HJ, Hwang SJ. Efficacy of rhBMP-2/Hydroxyapatite on Sinus Floor Augmentation: A Multicenter, Randomized Controlled Clinical Trial. J Dent Res. 2015 Sep;94(9 Suppl):158S-65S. doi: 10.1177/0022034515594573. Epub 2015 Jul 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Novosis(bongros/BMP-2) and Bio-oss in people with Regeneration of Alveolar Tissue After Maxillary Sinus Floor Augmentation, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01634308, 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 13 Jul 2012.