drugset / Trial / NCT07186166

Sinus Augmentation With Allograft-Bone Substitute in Severe Maxillary Atrophy

NCT07186166 ↗

NaSingle-groupOpen-labelOther

Summary

This study was conducted in two phases. In Phase 1, lateral window sinus floor augmentation was performed using a mixture of hydroxyapatite (30%) and β-tricalcium phosphate (70%) combined with autologous platelet-rich fibrin (PRF). Standard surgical protocols were followed, including prophylactic antibiotics, local anesthesia, and careful elevation of the Schneiderian membrane prior to graft placement. In Phase 2, after six months of healing, core bone biopsies were harvested with a trephine drill at the planned implant site for histological analysis. Specimens were processed using standardized laboratory protocols and evaluated with light microscopy and digital imaging. Quantitative histomorphometric analysis was performed using ImageJ software to determine the area fractions of newly formed bone and residual graft material. Following biopsy retrieval, dental implants were placed and primary stability was measured with the Implant Stability Quotient (ISQ).

Timeline

Start
2022-01-01
Primary completion
2024-02-01
Completion
2024-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Osteon II Other / unclassified — —

Indications

No indication recorded.