An interventional study of Bioactive Glass Bone Graft (UNIGRAFT) and Xenograft Bone Graft (Bio-Oss) in Alveolar Bone Loss, Maxillary Sinus Disease and Tooth Loss, sponsored by Suez Canal University. Not yet recruiting. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-15.
Sponsored by Suez Canal University · Not applicable, Interventional, and Treatment
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.
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.
318 studies on the registry are indexed under Alveolar Bone Loss; 79 are open to participants now.
This study's planned enrollment of 20 is below the median of 25 across 269 interventional studies indexed under Alveolar Bone Loss.
Browse Alveolar Bone Loss studies →Suez Canal University is the lead sponsor of 164 studies on the registry; 38 are open to participants now.
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Exclusion Criteria:
History of radiotherapy in the head and neck region.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Bioactive Glass Bone Graft (UNIGRAFT)
Patients in this group will undergo maxillary sinus floor augmentation using a conventional xenograft material via open sinus lift approach.
Device: Xenograft Bone Graft (Bio-Oss)
A bioactive glass bone graft material (UNIGRAFT, Biomed Inc., USA) used for maxillary sinus floor augmentation via open sinus lift technique.
A commercially available bovine-derived xenograft material (Bio-Oss, Geistlich Pharma) used for maxillary sinus floor augmentation via open sinus lift technique.
Change in vertical bone height measured by CBCT
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
Time frame: 6 months after sinus augmentation
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual participant data (IPD) underlying the results of the study may be shared publicly or upon request after publication. Data sharing will be at the discretion of the principal investigator and will not require prior approval from external parties. The data will be used solely for academic and non-commercial purposes.
Supporting information: Statistical analysis plan, Informed consent form
Time frame: Data will be available beginning 6 months after the primary completion date and will be accessible for up to 3 years.
Access criteria: Qualified researchers may request access to the de-identified data by contacting the principal investigator. Access will be granted for academic purposes only. A data use agreement may be required.
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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