Randomized Comparison of Hydrogel-Enhanced Xenograft and Graftless Method for Maxillary Sinus Floor Augmentation Assessing Bone Growth and Tissue Healing for Dental Implant Placement

What this Trial Is About

This research evaluates augmentation techniques for the maxillary sinus floor in patients needing dental implants in areas with reduced bone height. It compares a new hydrogel-enhanced xenograft bone substitute with a graftless method that relies on the body forming bone after elevating the sinus membrane. The study aims to assess differences in tissue reaction, bone height, and bone quality between these two approaches. Participants undergo lateral maxillary sinus floor elevation either with the hydrogel-enhanced xenograft or with a graftless method involving stabilization of the elevated membrane using screws. This is done as a staged procedure, with implant placement planned after bone augmentation. The study includes two randomized groups one receiving the xenograft material and the other using membrane stabilization without graft material. During the study, participants will be monitored for postoperative swelling, pain, and tissue response. Radiographic imaging via CBCT will assess bone height and density before implant placement at 8 months. Bone samples will be collected for histological examination. Participant involvement includes follow-up visits to track healing and collect patient-reported symptoms, with the total study duration extending through the augmentation and implant preparation phases.

Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation