Comparing bone formation after sinus floor elevation with and without perforation
Assessment of the Effect of Sinus Floor Perforation During Sinus Floor Elevation on Bone Formation Within the Augmentation Material
This study is testing whether making a small hole in the sinus floor during a bone graft procedure helps patients grow more bone compared to just using the graft material alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT05362136 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of perforating the cortical sinus floor to enhance bone formation during sinus floor elevation procedures. Twelve patients requiring bilateral sinus floor elevation will participate in a split-mouth design, where one side will undergo perforation before the insertion of augmentation material, while the other side will serve as a control with only the augmentation material. The healing process will be monitored for 4-6 months, after which bone biopsies will be collected for histological analysis to assess the differences in bone formation between the two approaches.
Who should consider this trial
Good fit: Ideal candidates are patients needing bilateral sinus floor elevation with specific ridge dimensions.
Not a fit: Patients with uncontrolled periodontal disease or sinusitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved bone formation and better outcomes for patients receiving dental implants.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating a novel exploration in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * in need of bilateral sinus floor elevation * residual alveolar ridge height 2-6mm * residual alveolar ridge width \> 4mm Exclusion Criteria: * uncontrolled periodontal disease * acute or chronic sinusitis
Where this trial is running
Vienna
- University Clinic of Dentistry, Medical University of Vienna — Vienna, Austria (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.