Efficacy of Bioactive Glass vs. Xenograft in Maxillary Sinus Augmentation

ConditionsAlveolar Bone Loss Maxillary Sinus Disease Tooth Loss

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age20-65

SponsorSuez Canal University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Presence of systemic conditions that could affect bone healing (e.g., uncontrolled diabetes, osteoporosis).

Heavy smoking (more than 10 cigarettes/day).

Active sinus pathology or previous sinus surgery.

Pregnant or breastfeeding women.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: Bioactive Glass GroupExperimental treatment 1 intervention

Group B: Xenograft GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suez Canal University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: