Efficacy of Bioactive Glass vs. Xenograft in Maxillary Sinus Augmentation

NCT07125846 | Not Yet Recruiting

• 1 other identifier: MF-SINUS-2025
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alveolar Bone Loss; Maxillary Sinus Disease; Tooth Loss

Keywords

Maxillary Sinus Augmentation; Bioactive Glass; Xenograft; Sinus Lift; Bone Grafting; Dental Implant

Outcome Measures

Primary Outcomes (1)

• 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

  6 months after sinus augmentation

Study Arms (2)

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.

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.

Device: Xenograft Bone Graft (Bio-Oss)

Interventions

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.

Bioactive Glass Group

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.

Xenograft Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

Related Publications (2)

• 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.

  PMID: 11359485 BACKGROUND

• 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.

  PMID: 29246424 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Alveolar Bone Loss; Tooth Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Mohamed A Elsholkamy, Professor

  Suez Canal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa A Elfeky, BDS

CONTACT

+201000543404; mostafa_elfeky@dent.suez.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm parallel randomized controlled trial with 1:1 allocation ratio.

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 15, 2025
• Study Start: October 15, 2025
• Primary Completion: February 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• 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.