Study protocol: a randomized controlled trial evaluating the effectiveness of a novel in-situ forming bone graft for lateral bone augmentation in compromised alveolar sites

Abstract Background Synthetic bone substitutes offer a promising alternative to autografts, allografts, and xenografts for bone tissue regeneration, particularly for lateral bone augmentation (LBA) in the alveolar ridge. Traditional guided bone regeneration techniques for horizontal and vertical ridge defects are complex and associated with higher complication risks. This study introduces a novel in-situ forming scaffold (IFS) that solidifies at the surgery site, providing a stable framework for bone growth. Unlike animal-derived grafts, the IFS scaffold minimizes immunogenicity and disease transmission risks. This trial marks the first-in-human clinical evaluation of a patented IFS following successful preclinical studies. Its safety and efficacy will be assessed in comparison to Bio-Oss Spongiosa through radiographic and histological analyses, offering a novel synthetic approach to bone regeneration. Methods This randomized, controlled clinical trial will include 37 participants with lateral alveolar bone defects in the anterior region. Participants will be randomized to receive either Bio-Oss Spongiosa or the IFS scaffold. The primary outcomes include the scaffold’s safety and effectiveness in promoting bone regeneration, assessed radiographically and histologically at baseline, postoperatively, and after a 7.5-month healing period. Secondary outcomes involve implant stability and bone formation at re-entry. Blinding will be maintained for participants, outcome assessors, and statisticians. Discussion This trial represents the first evaluation of an in-situ forming scaffold for LBA. The IFS scaffold is expected to provide outcomes comparable to traditional grafts in bone fill, stability, and implant support, offering a safer synthetic alternative for alveolar bone regeneration. If successful, the findings may significantly advance techniques for alveolar ridge augmentation.