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Not yet recruiting NCT07280117

Magnesium-based Bioresorbable Pins for Membrane Fixation

Observational Sinus Floor Augmentation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Sinus Floor Augmentation. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Magnesium-based Bioresorbable Pins for Membrane Fixation in Case of Sinus Floor Elevation (SFE): a Prospective Case Series

Overview

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.

Primary outcome measures

  • Visually successful fixation of the membrane: [Time frame: During SFE]
Secondary outcome measures (1)
  • Material degradation of the Mg pins [Time frame: after 6 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Pregnancy (as contraindicated for CBCT imaging that is routinely performed)
  • Manifest hepato-renal disease
  • Inability or unwillingness to give informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07280117 · 2025-01789

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗