Sinus Floor AugmentationNCT02384291
Sinus Floor Elevation Using Alpha-Bio's GRAFT Natural Bovine Bone vs. Commercially Available Bone Graft
A study testing Alpha-Bio GRAFT Natural Bovine Bone and natural bone substitute in people with Sinus Floor Augmentation, run by Alpha - Bio Tec Ltd..
Trial summary
This clinical study is designed to compare the regenerative outcome of using separately two different Xenografts during sinus floor augmentation. Aim of this prospective randomized-controlled clinical trial is to compare the regenerative results of Alpha-Bio's GRAFT Natural Bovine Bone versus commercially available… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinus Floor Augmentation
- What is being tested?
- Alpha-Bio GRAFT Natural Bovine Bone and natural bone substitute
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Jun 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will present with a moderately or severely atrophic posterior maxilla with 1-6 mm residual alveolar bone will be selected for the study.
- Men and women over the age of 18 years.
- Patient has signed the Informed Consent.
Who cannot join
- Chronic steroid therapy,
- Uncontrolled diabetes,
- Cardiovascular disease,
- Past irradiation of head and neck
- Maxillary sinus cysts,
- Active chronic sinusitis,
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- Smoking more than ten cigarettes per day during the 3 months preceding this study .
- Malignant disease in the 5 years preceding this study
- Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia
- Disease that compromise the immune system
- Psychiatric disorder
- Hypersensitivity to titanium, collagen or bovine bone.
- Women who are pregnant or nursing.
- Patients with non-treated periodontal disease.
- Medical and/or general contraindications for intraoral surgical procedures
About this study
Official title: Sinus Floor Elevation Using Alpha-Bio's GRAFT Natural Bovine Bone Versus Commercially Available Bone Graft. A Prospective Randomized Clinical Trial
This clinical study is designed to compare the regenerative outcome of using separately two different Xenografts during sinus floor augmentation.
Aim of this prospective randomized-controlled clinical trial is to compare the regenerative results of Alpha-Bio's GRAFT Natural Bovine Bone versus commercially available bone graft after two-step sinus floor elevations by clinical and histological analysis.
Clinical Parameters are wound healing parameters, radiological volume stability and implant survival rates. Histological parameters are based on a histomorphometrical analysis of trephine cores harvested in progress of implant bed preparation.
- Conditions
- Sinus Floor Augmentation
- Being tested
- Alpha-Bio GRAFT Natural Bovine Bone, natural bone substitute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-Bio GRAFT Natural Bovine BoneDevice
Pure Hydroxyapatite ceramic mineral with high similarity to the human bone
natural bone substituteDevice
natural bone substitute material derived from the mineral portion of bovine bone
| Study group | Role | What they receive |
|---|---|---|
| Alpha-Bios GRAFT Natural Bovine Bone treatment | Experimental | Pure Hydroxyapatite ceramic mineral with high similarity to the human bone Receives: Device: Alpha-Bio GRAFT Natural Bovine Bone |
| natural bone substitute | Active comparator | natural bone substitute material derived from the mineral portion of bovine bone Receives: Device: natural bone substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological bone formation following sinus floor augmentation [ evaluated by biopsies harvested from the implant sites]
Measured: 6 months
Secondary outcomes (1)
Bone volume-stable results six months following augmentation procedures [ demonstrated by X-ray evaluation].
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startMay 2014
- Primary completionDec 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus Floor AugmentationStudies 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
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alpha - Bio Tec Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Rothamel, Priv-Doz Dr., Principal investigator, Department of Craniomaxillofacial and Plastic Surgery University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384291
- Sponsor's protocol ID
- ABT-BG-01
- Status last verified
- Sep 2018
- First submitted
- 26 Feb 2015
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sinus Floor Elevation Using Alpha-Bio's GRAFT Natural Bovine Bone Versus Commercially Available Bone Graft. A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02384291
- Acronym / sponsor ID
- ABT-BG-01
- Conditions
- Sinus Floor Augmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Alpha - Bio Tec Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 10 Mar 2015 (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 clinical study is designed to compare the regenerative outcome of using separately two different Xenografts during sinus floor augmentation.
Aim of this prospective randomized-controlled clinical trial is to compare the regenerative results of Alpha-Bio's GRAFT Natural Bovine Bone versus commercially available bone graft after two-step sinus floor elevations by clinical and histological analysis.
Clinical Parameters are wound healing parameters, radiological volume stability and implant survival rates. Histological parameters are based on a histomorphometrical analysis of trephine cores harvested in progress of implant bed preparation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alpha-Bios GRAFT Natural Bovine Bone treatment | Experimental | Device: Alpha-Bio GRAFT Natural Bovine BonePure Hydroxyapatite ceramic mineral with high similarity to the human bone |
| natural bone substitute | Active comparator | Device: natural bone substitutenatural bone substitute material derived from the mineral portion of bovine bone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who will present with a moderately or severely atrophic posterior maxilla with 1-6 mm residual alveolar bone will be selected for the study.
- Men and women over the age of 18 years.
- Patient has signed the Informed Consent.
Key exclusion criteria (15 listed)
- Chronic steroid therapy,
- Uncontrolled diabetes,
- Cardiovascular disease,
- Past irradiation of head and neck
- Maxillary sinus cysts,
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 |
|---|---|---|
| Alpha-Bio GRAFT Natural Bovine BonePure Hydroxyapatite ceramic mineral with high similarity to the human bone | Device | Alpha-Bios GRAFT Natural Bovine Bone treatment |
| natural bone substitutenatural bone substitute material derived from the mineral portion of bovine bone | Device | natural bone substitute |
Primary outcome
Histological bone formation following sinus floor augmentation [ evaluated by biopsies harvested from the implant sites]
Time frame: 6 months
1 secondary outcome
Bone volume-stable results six months following augmentation procedures [ demonstrated by X-ray evaluation].
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Sponsor siteLink provided by the sponsor.
Related trials for Sinus Floor Augmentation
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The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
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Smart Scaffolds, Stronger Smiles Smarter Healing: AI-Boosted Multiphasic Scaffold Design for PDL Regeneration
Regeneration of Alveolar Tissue After Maxillary Sinus Floor Augmentation
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Closed Sinus Augmentation With a Calcium Phosphosilicate Putty
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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.
Daniel Rothamel, Priv-Doz Dr. principal investigator
Department of Craniomaxillofacial and Plastic Surgery University Hospital of Cologne
Questions about this trial
What is this clinical trial studying?
A study testing Alpha-Bio GRAFT Natural Bovine Bone and natural bone substitute in people with Sinus Floor Augmentation, run by Alpha - Bio Tec Ltd..
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 3 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 16 Jul 2019. 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?
Results are not available in the source record.
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?
Histological bone formation following sinus floor augmentation [ evaluated by biopsies harvested from the implant sites] (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2019.