Efficacy of Bioactive Glass vs. Xenograft in Maxillary Sinus Augmentation

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07125846
• Lead Sponsor: Suez Canal University

Brief 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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-14
• Study First Submitted QC: 2025-08-14
• Last Update Submitted: 2025-08-14
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-15
• Study Start: 2025-10-15
• Primary Completion: 2026-02-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in vertical bone height measured by CBCT	6 months after sinus augmentation	Evaluation of the change in vertical bone height in the grafted sinus area using CBCT imaging. CBCT scans will be taken preoperatively and at 6 months postoperatively to assess bone formation