Sinus Floor AugmentationNCT07280117
Magnesium-based Bioresorbable Pins for Membrane Fixation
An observational study of Sinus Floor Augmentation, run by Valentin Herber.
Trial summary
The goal of this research project is to assess the clinical performance and degradation of bioresorbable Mg- based pins for membrane fixation in patients with sinus floor elevation. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sinus Floor Augmentation
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- Adult, Older adult
Study population: Patient requiring a staged approach SFE
Who may be able to join
- Healthy patients in the aged > 21 years.
- fully or partially edentulous with unilaterally or bilaterally missing upper premolars or molars and an insufficient residual bone height to guarantee primary stability of implants; and requiring a staged approach of SFE and implant surgery
- Subject has been informed and signed the informed consent
Who cannot join
- Smoking more than 9 cigarettes per day
- Irradiation in the maxilla-facial region,
- A known metabolic skeletal disease (such as osteomalacia, osteoporosis or osteogenesis imperfecta) or medications that can affect the bone structure
- Allergies / intolerances to the materials
- Known malignancy
- Epilepsy or anamnestic evidence of recurrent falls
Show all 9Show fewer
- Pregnancy (as contraindicated for CBCT imaging that is routinely performed)
- Manifest hepato-renal disease
- Inability or unwillingness to give informed consent.
About this study
Official title: Magnesium-based Bioresorbable Pins for Membrane Fixation in Case of Sinus Floor Elevation (SFE): a Prospective Case Series
The goal of this research project is to assess the clinical performance and degradation of bioresorbable Mg- based pins for membrane fixation in patients with sinus floor elevation.
- Conditions
- Sinus Floor Augmentation
What is being measured
The primary outcome is the main question the study is designed to answer.
Visually successful fixation of the membrane:
Measured: During SFE
Secondary outcomes (1)
Material degradation of the Mg pins
Measured: after 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 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Aug 2028 (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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valentin Herber
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Valentin Herber, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280117
- Sponsor's protocol ID
- 2025-01789
- Other IDs
- 2025
- Status last verified
- Nov 2025
- First submitted
- 1 Dec 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium-based Bioresorbable Pins for Membrane Fixation in Case of Sinus Floor Elevation (SFE): a Prospective Case Series
- ClinicalTrials.gov ID
- NCT07280117
- Acronym / sponsor ID
- 2025-01789
- Conditions
- Sinus Floor Augmentation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Valentin HerberUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 12 Dec 2025 (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.
The goal of this research project is to assess the clinical performance and degradation of bioresorbable Mg- based pins for membrane fixation in patients with sinus floor elevation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient requiring a staged approach SFE
Key inclusion criteria (3 listed)
- Healthy patients in the aged > 21 years.
- fully or partially edentulous with unilaterally or bilaterally missing upper premolars or molars and an insufficient residual bone height to guarantee primary stability of implants; and requiring a staged approach of SFE and implant surgery
- Subject has been informed and signed the informed consent
Key exclusion criteria (9 listed)
- Smoking more than 9 cigarettes per day
- Irradiation in the maxilla-facial region,
- A known metabolic skeletal disease (such as osteomalacia, osteoporosis or osteogenesis imperfecta) or medications that can affect the bone structure
- Allergies / intolerances to the materials
- Known malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visually successful fixation of the membrane:
Time frame: During SFE
1 secondary outcome
Material degradation of the Mg pins
Time frame: after 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sinus Floor Augmentation, run by Valentin Herber.
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 9 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: opening soon, as of the sponsor's last update on 12 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Visually successful fixation of the membrane: (time frame: During SFE). 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 12 Dec 2025.