Assessment of Bone Density Following Application of BMAC Around Zygomatic Implant

NCT07657026 | Not Yet Recruiting DMC

• 1 other identifier: omfs3-3-20-
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective case series is designed to evaluate the effect of autologous bone marrow aspirate concentrate applied around zygomatic implants placed via the intrasinus approach. The study will include adult patients with severe maxillary atrophy requiring zygomatic implant rehabilitation. BMAC will be prepared from iliac crest aspirate and loaded on gelatin sponge at the implant site. Peri-implant bone density will be assessed using CBCT at baseline and 6 months postoperatively. Secondary implant stability will be measured using resonance frequency analysis. (Recruitment has not started yet)

Conditions

Severe Maxillary Atrophy

Keywords

zygomatic implants; Bone marrow aspirate concentrate; Bone density; CBCT; Intrasinus approach; Mesenchymal stem cells; Osseointegration; Secondary stability

Outcome Measures

Primary Outcomes (1)

• Bone density around zygomatic implants

  Bone density measured using Cone Beam Computed Tomography (CBCT) and expressed in Hounsfield Units (HU)

  6 months postoperatively

Secondary Outcomes (1)

• secondary stability of zygomatic implants

  6 months postoperatively

Study Arms (1)

zygomatic implant group

EXPERIMENTAL

All eligible participants with atrophied maxilla receiving zygomatic implant placement for fixed prosthetic rehabilitation.

Procedure: zygomatic implants placement

Interventions

zygomatic implants placement PROCEDURE

placement of zygomatic implants via the intrasinus approach in the posterior maxilla of patients with severely atrophied maxilla. Bone marrow aspirate concentrate prepared by double centrifugation of bone marrow aspirated from anterior iliac crest of the patient then loaded on gelatine sponge and applied around the zygomatic implants. Conventional implants may be placed in the anterior maxilla. Procedure performed under general anaesthesia with propofol induction and sevoflurane maintenance.

zygomatic implant group

Eligibility Criteria

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

You may qualify if:

• Patients over 18 years old.
• Patients requiring rehabilitation with zygomatic implants in the posterior maxilla.
• Patients who are willing to participate and able to provide informed consent.

You may not qualify if:

• Pregnant women.
• Individuals with history of radiation therapy or other contraindications for surgery.
• Patients with bone marrow diseases.
• Patients with local infections at intraoral surgical site or bone marrow aspiration site.
• Patients unwilling to sign the written informed consent.
• Heavy smokers \>20 cigarettes per day.
• Patients taking contraindicated drugs such as bisphosphonates.
• Patients with sinus pathology or acute sinusitis.
• Patients with malignancy or pathology of maxilla.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University , Department of Oral and Maxillofacial Surgery

Cairo, Cairo Governate, 11562, Egypt

Location

MeSH Terms

Conditions

Atrophic Maxilla

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Maxillary Diseases; Jaw Diseases; Stomatognathic Diseases

Study Officials

• Ramy Ragab Elbeialy, Professor of OMFS

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tilal Sidahmed Ahmed, BDS

CONTACT

00201555225441; Tilal.sidahmed@dentistry.cu.edu.eg

Walaa Kadry Hafez, Associate professor of OMFS

CONTACT

00201061527359; walaakadry@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking is used. Both the surgeon and participant are aware of the intervention.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in oral and maxillofacial surgery department

Model Details: All participants will receive zygomatic implants with bone marrow aspirate concentrate (BMAC) loaded on gelatine sponge around the implants via intrasinus approach

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 18, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)