Magnesium-based Bioresorbable Pins for Membrane Fixation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sinus Floor Augmentation

• Study Type: Observational
• Enrollment (Estimated): 12

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patient requiring a staged approach SFE

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visually successful fixation of the membrane:	During SFE

Secondary Outcome Measures

Outcome Measure	Time Frame
Material degradation of the Mg pins	after 6 months

Collaborators and Investigators

• Sponsor: Valentin Herber

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2025-01789