Magnesium-based Bioresorbable Pins for Membrane Fixation

NCT ID: NCT07280117

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2028-08-01

Brief 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.

Conditions

Sinus Floor Augmentation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valentin Herber

OTHER

Sponsor Role: lead

Responsible Party

Valentin Herber

Dr.med.dent.

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

2025-01789

Identifier Type: -

Identifier Source: org_study_id