Maxillary Sinus Floor AugmentationNCT04381455
Evaluation of OSSIX® Bone in Sinus Elevation
An observational study of Maxillary Sinus Floor Augmentation, run by Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo at 1 site in Italy.
Trial summary
A post marketing observational study to evaluate clinical performance of OSSIX Bone in maxillary sinus elevation procedure. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Maxillary Sinus Floor Augmentation
- What is being tested?
- OSSIX Bone
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 4 May 2020to 1 Jan 2022
- Phase
- Observational
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that need sinus elevation
Who may be able to join
- Patient requiring vertical elevation of the maxillary sinus.
- Residual alveolar bone height of edentulous maxilla below the floor of the maxillary sinus of > 4-5mm.
- Males and females between 30-80 years old
- Patients with healthy periodontal conditions (Treated periodontitis, PI<25%, BoP<25%)
- Patients that are willing to sign an informed consent and participate in a clinical study
- Generally fit and healthy and able to undergo oral surgical procedures under local anesthesia.
- Teeth at the surgical site which required removal were extracted a minimum of 12 weeks prior to sinus floor elevation.
Who cannot join
- Patients who smoke over 5 cigarettes/day
- Pregnancy (confirmed by verbal inquiry)
- Chronic systemic pathologies (e.g. diabetes) and neoplastic of the Oro-Facial District 4.
- Patients taking bisphosphonates
- Any sites where an implant already failed sites
- Untreated Periodontitis
Show all 15Show fewer
- Dental sites with acute infections
- Chronic inflammatory diseases of the oral cavity
- Autoimmune diseases (cortisone intake)
- Allergy declared to one or more medicaments to be used during treatment
- Alcoholics patients and/or drug addicts
- Patients with known collagen hypersensitivity.
- Patients with sensitivity to porcine-derived materials.
- History or malignant tumours of the maxillary sinus
- History of local radiation therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of OSSIX® Bone in Maxillary Sinus Floor Augmentation
A post marketing observational study to evaluate clinical performance of OSSIX Bone in maxillary sinus elevation procedure.
- Conditions
- Maxillary Sinus Floor Augmentation
- Being tested
- OSSIX Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSSIX BoneDevice
subjects will be implanted with OSSIX Bone during sinus elevation surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Bone height from baseline
Measured: 1 year
Difference in bone volume
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start4 May 2020
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Canullo, Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
- Investigators
- Luigi Canullo, DDS, PhD, Principal investigator, Study site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381455
- Sponsor's protocol ID
- DD-01
- Status last verified
- Feb 2022
- First submitted
- 7 May 2020
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of OSSIX® Bone in Maxillary Sinus Floor Augmentation
- ClinicalTrials.gov ID
- NCT04381455
- Acronym / sponsor ID
- DD-01
- Conditions
- Maxillary Sinus Floor Augmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Studio Odontoiatrico Associato Dr. P. Cicchese e L. CanulloUniversity, hospital or other
- Study start
- 4 May 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 8 May 2020 (actual)
- 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.
A post marketing observational study to evaluate clinical performance of OSSIX Bone in maxillary sinus elevation procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that need sinus elevation
Key inclusion criteria (7 listed)
- Patient requiring vertical elevation of the maxillary sinus.
- Residual alveolar bone height of edentulous maxilla below the floor of the maxillary sinus of > 4-5mm.
- Males and females between 30-80 years old
- Patients with healthy periodontal conditions (Treated periodontitis, PI<25%, BoP<25%)
- Patients that are willing to sign an informed consent and participate in a clinical study
Key exclusion criteria (15 listed)
- Patients who smoke over 5 cigarettes/day
- Pregnancy (confirmed by verbal inquiry)
- Chronic systemic pathologies (e.g. diabetes) and neoplastic of the Oro-Facial District 4.
- Patients taking bisphosphonates
- Any sites where an implant already failed sites
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 |
|---|---|---|
| OSSIX Bonesubjects will be implanted with OSSIX Bone during sinus elevation surgery | Device | – |
Primary outcome
Difference in Bone height from baseline
Time frame: 1 year
Difference in bone volume
Time frame: 1 year
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 23 Feb 2022.
- 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.
Luigi Canullo, DDS, PhD principal investigator
Study site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maxillary Sinus Floor Augmentation, run by Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo at 1 site in Italy.
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 7 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: finished, as of the sponsor's last update on 23 Feb 2022. 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 Italy. 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.
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?
Difference in Bone height from baseline (time frame: 1 year). The study lists 2 primary outcomes in all. 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 Feb 2022; AzTrials last refreshed its copy on 28 Oct 2026.