Maxillary Sinus Floor AugmentationNCT02865590
Clinical and Histological Evaluation of Deproteinizated Bovine Bone Allograft and Lyophilized Equine Bone Allograft for Sinus Lift.
A study testing sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy) and Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy) in people with Maxillary Sinus Floor Augmentation, run by University of L'Aquila.
Trial summary
The sinus infiltration technique for sinus floor elevation has been used successfully when a reduced vertical height is available in the posterior maxilla. However, the effect of the different graft material on the volume and on the quality of new bone formed has not been fully investigated. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Sinus Floor Augmentation
- What is being tested?
- sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy) and Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- bilateral atrophy of the maxilla;
- bone ridge <= 6mm
Who cannot join
- severe systemic diseas (ASA III -IV) bisphosphonate therapy or a history of up to 3 years history of radiation therapy to neck and head area sinusitis pregnancy subjects not able to consent to participate in the study.
About this study
Official title: Clinical and Histological Evaluation of Demineralized Bone Allograft and Lyophilized Equine Bone Allograft for Sinus Lift: Double Blind, Parallel, Randomized Clinical Trial.
The sinus infiltration technique for sinus floor elevation has been used successfully when a reduced vertical height is available in the posterior maxilla. However, the effect of the different graft material on the volume and on the quality of new bone formed has not been fully investigated. The aim of this study is to evaluate the clinical and histological effect of a test material, lyophilized equine bone (Bio-gen®), compared with control material, deproteinized bovine bone (Endobon®), in the sinus lift techniques with lateral approach.
- Conditions
- Maxillary Sinus Floor Augmentation
- Being tested
- sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy), Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy)
- Keywords
- Maxillary Sinus/surgery, Bone Substitutes, Radiography, Panoramic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy)Device
Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy)Device
| Study group | Role | What they receive |
|---|---|---|
| Lyophilized Equine Bone Allograft | Experimental | Sinus Lift with Lyophilized Equine Bone Allograft Receives: Device: sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy) |
| deproteinized bovine bone allograft | Active comparator | Sinus lift with deproteinized bovine bone allograft Receives: Device: Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histomorphometric Evaluation of New Bone Formation.
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 posted12 Aug 2016 (estimated)
- Study startJun 2011
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Maxillary 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Marchetti, University of L'Aquila
- Investigators
- GIUSEPPE MARZO, DMD, Study chair, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865590
- Sponsor's protocol ID
- Prot.001/luglio2010
- Status last verified
- Mar 2020
- First submitted
- 3 Oct 2015
- Last updated
- 23 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Histological Evaluation of Demineralized Bone Allograft and Lyophilized Equine Bone Allograft for Sinus Lift: Double Blind, Parallel, Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02865590
- Acronym / sponsor ID
- Prot.001/luglio2010
- Conditions
- Maxillary Sinus Floor Augmentation
- Keywords
- Maxillary Sinus/surgery, Bone Substitutes, Radiography, Panoramic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Posted 23 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The sinus infiltration technique for sinus floor elevation has been used successfully when a reduced vertical height is available in the posterior maxilla. However, the effect of the different graft material on the volume and on the quality of new bone formed has not been fully investigated. The aim of this study is to evaluate the clinical and histological effect of a test material, lyophilized equine bone (Bio-gen®), compared with control material, deproteinized bovine bone (Endobon®), in the sinus lift techniques with lateral approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lyophilized Equine Bone Allograft | Experimental | Device: sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy)Sinus Lift with Lyophilized Equine Bone Allograft |
| deproteinized bovine bone allograft | Active comparator | Device: Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy)Sinus lift with deproteinized bovine bone allograft |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- bilateral atrophy of the maxilla;
- bone ridge <= 6mm
Key exclusion criteria (1 listed)
- severe systemic diseas (ASA III -IV) bisphosphonate therapy or a history of up to 3 years history of radiation therapy to neck and head area sinusitis pregnancy subjects not able to consent to participate in the study.
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 |
|---|---|---|
| sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy) | Device | Lyophilized Equine Bone Allograft |
| Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy) | Device | deproteinized bovine bone allograft |
Primary outcome
Histomorphometric Evaluation of New Bone Formation.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Smart Scaffolds, Stronger Smiles Smarter Healing: AI-Boosted Multiphasic Scaffold Design for PDL Regeneration
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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.
GIUSEPPE MARZO, DMD study chair
University of L'Aquila
Questions about this trial
What is this clinical trial studying?
A study testing sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy) and Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy) in people with Maxillary Sinus Floor Augmentation, run by University of L'Aquila.
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 2 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 23 Mar 2020. 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?
Yes. Results are posted in the registry (first posted 23 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Histomorphometric Evaluation of New Bone Formation. (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 23 Mar 2020.