Efficacy of Bioactive Glass vs. Xenograft in Maxillary Sinus Augmentation

NCT ID: NCT07125846

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2026-04-01

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.

Conditions

Alveolar Bone Loss; Maxillary Sinus Disease; Tooth Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bioactive Glass Group

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.

Group Type: EXPERIMENTAL

Bioactive Glass Bone Graft (UNIGRAFT)

Intervention Type: DEVICE

A bioactive glass bone graft material (UNIGRAFT, Biomed Inc., USA) used for maxillary sinus floor augmentation via open sinus lift technique.

Xenograft Group

Patients in this group will undergo maxillary sinus floor augmentation using a conventional xenograft material via open sinus lift approach.

Group Type: ACTIVE_COMPARATOR

Xenograft Bone Graft (Bio-Oss)

Intervention Type: DEVICE

A commercially available bovine-derived xenograft material (Bio-Oss, Geistlich Pharma) used for maxillary sinus floor augmentation via open sinus lift technique.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed A Elsholkamy, Professor

Role: PRINCIPAL_INVESTIGATOR

Suez Canal University

Central Contacts

Mostafa A Elfeky, BDS

Role: CONTACT

mostafa_elfeky@dent.suez.edu.eg

+201000543404

References

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.

Reference Type: BACKGROUND

PMID: 11359485 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29246424 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

https://www.unicarebiomedical.com/dental-supplies/unigraft.html

Official product page for Unigraft® bioactive glass synthetic bone graft used in maxillary sinus augmentation procedures.

Other Identifiers

MF-SINUS-2025

Identifier Type: -

Identifier Source: org_study_id