Alveolar Bone LossBIOXENONCT07125846
Efficacy of Bioactive Glass vs. Xenograft in Maxillary Sinus Augmentation
A study testing Bioactive Glass Bone Graft (UNIGRAFT) and Xenograft Bone Graft (Bio-Oss) in people with Alveolar Bone Loss and Maxillary Sinus Disease, run by Suez Canal University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Alveolar Bone Loss, Maxillary Sinus Disease, Tooth Loss
- What is being tested?
- Bioactive Glass Bone Graft (UNIGRAFT) and Xenograft Bone Graft (Bio-Oss)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Alveolar Bone Loss, Maxillary Sinus Disease, Tooth Loss
- Being tested
- Bioactive Glass Bone Graft (UNIGRAFT), Xenograft Bone Graft (Bio-Oss)
- Keywords
- Maxillary Sinus Augmentation, Bioactive Glass, Xenograft, Sinus Lift, Bone Grafting, Dental Implant
- Medical subject headings
- Alveolar Bone Loss, Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioactive Glass Bone Graft (UNIGRAFT)Device
A bioactive glass bone graft material (UNIGRAFT, Biomed Inc., USA) used for maxillary sinus floor augmentation via open sinus lift technique.
Xenograft Bone Graft (Bio-Oss)Device
A commercially available bovine-derived xenograft material (Bio-Oss, Geistlich Pharma) used for maxillary sinus floor augmentation via open sinus lift technique.
| Study group | Role | What they receive |
|---|---|---|
| Bioactive Glass Group | Experimental | 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. Receives: Device: Bioactive Glass Bone Graft (UNIGRAFT) |
| Xenograft Group | Active comparator | Patients in this group will undergo maxillary sinus floor augmentation using a conventional xenograft material via open sinus lift approach. Receives: Device: Xenograft Bone Graft (Bio-Oss) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months after sinus augmentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start15 Oct 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel randomized controlled trial with 1:1 allocation ratio.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed A Elsholkamy, Professor, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125846
- Sponsor's protocol ID
- MF-SINUS-2025
- Acronym
- BIOXENO
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 11359485Pereira 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.
PubMed 29246424
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07125846
- Acronym / sponsor ID
- BIOXENO / MF-SINUS-2025
- Conditions
- Alveolar Bone Loss, Maxillary Sinus Disease, Tooth Loss
- Keywords
- Maxillary Sinus Augmentation, Bioactive Glass, Xenograft, Sinus Lift, Bone Grafting, Dental Implant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm parallel randomized controlled trial with 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Bioactive Glass Group | Experimental | Device: Bioactive Glass Bone Graft (UNIGRAFT)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. |
| Xenograft Group | Active comparator | Device: Xenograft Bone Graft (Bio-Oss)Patients in this group will undergo maxillary sinus floor augmentation using a conventional xenograft material via open sinus lift approach. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Bioactive Glass Group |
| 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. | Device | Xenograft Group |
Primary outcome
Change in vertical bone height measured by CBCT
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Background: PubMed 11359485Cordioli 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.
- Background: PubMed 29246424Pereira 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.
- Official product page for Unigraft® bioactive glass synthetic bone graft used in maxillary sinus augmentation procedures.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed A Elsholkamy, Professor principal investigator
Suez Canal University
Questions about this trial
What is this clinical trial studying?
A study testing Bioactive Glass Bone Graft (UNIGRAFT) and Xenograft Bone Graft (Bio-Oss) in people with Alveolar Bone Loss and Maxillary Sinus Disease, run by Suez Canal University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mostafa A Elfeky, BDS (+201000543404, mostafa_elfeky@dent.suez.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vertical bone height measured by CBCT (time frame: 6 months after sinus augmentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07125846, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.