NCT07280117

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
27mo left

Started Dec 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Dec 2025Aug 2028

First Submitted

Initial submission to the registry

December 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

December 12, 2025

Status Verified

November 1, 2025

Enrollment Period

1.2 years

First QC Date

December 1, 2025

Last Update Submit

December 1, 2025

Conditions

Sinus Floor Augmentation

Outcome Measures

Primary Outcomes (1)

  • Visually successful fixation of the membrane:

    During SFE

Secondary Outcomes (1)

  • Material degradation of the Mg pins

    after 6 months

Eligibility Criteria

Age21 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient requiring a staged approach SFE

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.med.dent.

Study Record Dates

First Submitted

December 1, 2025

First Posted

December 12, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

August 1, 2028

Last Updated

December 12, 2025

Record last verified: 2025-11