Assessment of Bone Density Following Application of BMAC Around Zygomatic Implant. (BMAC)

June 15, 2026 updated by: Tilal Sidahmed Mohamed Ahmed, Cairo University

Assessment of Bone Density Following Application of Bone Marrow Aspirate Concentrate Around Zygomatic Implants (Via the Intrasinus Approach): A Case Series Study

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Zygomatic implants provide a viable option for rehabilitation of the severely atrophic maxilla. However, achieving optimal osseointegration remains a challenge due to poor bone quality in the posterior maxilla. Bone marrow aspirate concentrate contains mesenchymal stem cells and growth factors that may enhance local bone formation.

Knowledge Gap:

BMAC has been investigated with conventional dental implants, but its use with zygomatic implants placed via the intrasinus approach is limited to isolated case reports. A systematic evaluation of its effect on peri-implant bone density and stability in this specific context is lacking. This case series addresses that gap.

Study Design and Setting:

This is a single-center, prospective case series planned at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University. The primary hypothesis is that BMAC application will improve bone density and secondary stability of zygomatic implants at 6 months. (Recruitment has not commenced.)

Surgical Procedure:

Under general anaesthesia, approximately 30 ml of bone marrow will be aspirated from the anterior iliac crest. The aspirate will be processed using a double centrifugation protocol to obtain the buffy coat layer, which will then be loaded onto a gelatine sponge. Zygomatic implants will be placed through a lateral sinus window using the intrasinus trajectory. The BMAC-loaded sponge will be applied around the implant prior to closure. Conventional implants will be placed in the anterior maxilla to support the planned full-arch prosthesis.

Follow-up Protocol:

Patients will be reviewed weekly during the first month, then monthly for 6 months. Cone beam computed tomography will be performed immediately postoperatively and at 6 months to assess changes in bone density in Hounsfield Units. Resonance frequency analysis will be performed at 6 months to evaluate secondary implant stability. Adverse events will be recorded throughout the follow-up period.

Ethical Considerations:

The study protocol has been submitted to the Ethics Committee of Scientific Research, Faculty of Dentistry, Cairo University and is currently pending approval. A written informed consent will be obtained from all participants in Arabic prior to enrollment. Patient data will be coded and stored in a secure, password-protected database accessible only to the research team. The study is self-funded with no conflicts of interest declared.

Outcomes:

The primary outcome is the change in peri-implant bone density at 6 months. Secondary outcome includes secondary stability of the implants . Data will be summarized descriptively given the case series design.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Cairo Governate
      • Cairo, Cairo Governate, Egypt, 11562
        • Faculty of Dentistry, Cairo University , Department of Oral and Maxillofacial Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: zygomatic implant group
All eligible participants with atrophied maxilla receiving zygomatic implant placement for fixed prosthetic rehabilitation.
Procedure: zygomatic implants placement
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone density around zygomatic implants
Time Frame: 6 months postoperatively
Bone density measured using Cone Beam Computed Tomography (CBCT) and expressed in Hounsfield Units (HU)
6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
secondary stability of zygomatic implants
Time Frame: 6 months postoperatively
Implant stability measured using Resonance Frequency Analysis (RFA) device (Osstell) and expressed as Implant Stability Quotient (ISQ)
6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Ramy Ragab Elbeialy, Professor of OMFS, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

June 15, 2027

Study Registration Dates

First Submitted

June 15, 2026

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 18, 2026

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • omfs3-3-20-

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to ethical restrictions and patient privacy regulations.

IPD will be shared after publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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