Alveolar Bone Loss, Maxillary Sinus Disease, Tooth Loss
Conditions
Keywords
Maxillary Sinus Augmentation, Bioactive Glass, Xenograft, Sinus Lift, Bone Grafting, Dental Implant
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.
Interventions
DEVICEBioactive 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.
DEVICEXenograft 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.
Sponsors
Suez Canal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two-arm parallel randomized controlled trial with 1:1 allocation ratio.
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactMostafa A Elfeky, BDS
Outcome results
None listed