Efficacy of Bioactive Glass vs. Xenograft in Maxillary Sinus Augmentation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bioactive Glass Bone Graft (UNIGRAFT), Xenograft Bone Graft (Bio-Oss).
- Who it may be relevant to
- Registry conditions: Alveolar Bone Loss, Maxillary Sinus Disease, Tooth Loss. Basic parameters: 20 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in vertical bone height measured by CBCT [Time frame: 6 months after sinus augmentation]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Cordioli G, Mazzocco C, Schepers E, Brugnolo E, Majzoub Z. Maxillary sinus floor augmentation using bioactive glass granules and autogenous bone with simultaneous implant placement. Clinical and histological findings. Clin Oral Implants Res. 2001 Jun;12(3):270-8. doi: 10.1034/j.1600-0501.2001.012003270.x. PMID 11359485
- Pereira RS, Menezes JD, Bonardi JP, Griza GL, Okamoto R, Hochuli-Vieira E. Comparative study of volumetric changes and trabecular microarchitecture in human maxillary sinus bone augmentation with bioactive glass and autogenous bone graft: a prospective and randomized assessment. Int J Oral Maxillofac Surg. 2018 May;47(5):665-671. doi: 10.1016/j.ijom.2017.11.016. Epub 2017 Dec 13. PMID 29246424
Identifiers
NCT: NCT07125846 · MF-SINUS-2025