NCT07125846

Efficacy of Bioactive Glass vs. Xenograft in Maxillary Sinus Augmentation

Clinical, Radiographic and Histologic Assessment of the Efficacy of Bioactive Glass as a Novel Grafting Material in Maxillary Sinus Floor Augmentation: A Randomized Controlled Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Suez Canal University · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled study aims to evaluate the clinical, radiographic, and histologic efficacy of using bioactive glass bone graft (UNIGRAFT by Biomed Inc., USA) compared to a conventional xenograft in maxillary sinus augmentation procedures. A total of 20 patients classified as SA4 according to the Misch classification will be enrolled and randomly allocated into two groups. Outcomes will be assessed using Cone Beam Computed Tomography (CBCT) for vertical bone gain and, where applicable, histologic analysis. The study is conducted at the Faculty of Dentistry, Suez Canal University.

Detailed description

The aim of this clinical study is to compare the performance of a novel bioactive glass bone graft (UNIGRAFT) with a standard xenograft material in open sinus lift procedures for patients with severely atrophic maxillary posterior ridges (Misch SA4 classification). The trial is designed as a parallel-arm, randomized controlled study involving 20 patients. Each participant will undergo maxillary sinus augmentation using either the bioactive glass or the xenograft, followed by a healing period prior to implant placement. Radiographic evaluation using CBCT will be conducted to assess vertical bone height gain pre- and post-operatively. Additionally, histological samples may be obtained during implant placement in indicated cases to evaluate bone quality. The primary endpoint is vertical bone gain after 6 months, and secondary endpoints include bone density, complication rate, and histologic characteristics. The study will follow strict ethical guidelines and is approved by the institutional ethics committee of Suez Canal University.

Conditions

• Alveolar Bone Loss
• Maxillary Sinus Disease
• Tooth Loss

Interventions

Type	Name	Description
DEVICE	Bioactive Glass Bone Graft (UNIGRAFT)	A bioactive glass bone graft material (UNIGRAFT, Biomed Inc., USA) used for maxillary sinus floor augmentation via open sinus lift technique.
DEVICE	Xenograft Bone Graft (Bio-Oss)	A commercially available bovine-derived xenograft material (Bio-Oss, Geistlich Pharma) used for maxillary sinus floor augmentation via open sinus lift technique.

Timeline

• Start date: 2025-10-15
• Primary completion: 2026-02-01
• Completion: 2026-04-01
• First posted: 2025-08-15
• Last updated: 2025-08-15