Efficacy of Bioactive Glass vs. Xenograft in Maxillary Sinus Augmentation (BIOXENO)

Suez Canal University

Status: Not yet enrolling

Conditions: Maxillary Sinus Disease; Tooth Loss; Alveolar Bone Loss

Treatments: Device: Bioactive Glass Bone Graft (UNIGRAFT); Device: Xenograft Bone Graft (Bio-Oss)

Study type: Interventional

Funder types: Other

Identifiers

NCT07125846

MF-SINUS-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients requiring maxillary sinus floor augmentation for dental implant placement.
• Residual alveolar bone height ≤ 4 mm in posterior maxilla (SA4 classification).
• Age between 20 to 65 years.
• Good general health and able to attend scheduled follow-up visits.
• Signed written informed consent.

Exclusion criteria

• Presence of systemic conditions that could affect bone healing (e.g., uncontrolled diabetes, osteoporosis).

History of radiotherapy in the head and neck region.

• Heavy smoking (more than 10 cigarettes/day).
• Active sinus pathology or previous sinus surgery.
• Pregnant or breastfeeding women.
• Use of medications affecting bone metabolism (e.g., bisphosphonates or corticosteroids).
• Poor oral hygiene or untreated periodontal disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Bioactive Glass Group

Experimental group

Description:

Patients in this group will undergo maxillary sinus floor augmentation using bioactive glass bone graft material (UNIGRAFT, Biomed Inc., USA). The procedure will be performed via open sinus lift approach.

Treatment:

Device: Bioactive Glass Bone Graft (UNIGRAFT)

Xenograft Group

Active Comparator group

Description:

Patients in this group will undergo maxillary sinus floor augmentation using a conventional xenograft material via open sinus lift approach.

Treatment:

Device: Xenograft Bone Graft (Bio-Oss)