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Assessment of Bone Density Following Application of BMAC Around Zygomatic Implant

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07657026
Acronym
BMAC
Enrollment
10
Registered
2026-06-18
Start date
2026-06-15
Completion date
2027-06-15
Last updated
2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Maxillary Atrophy

Keywords

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

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)

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.

Interventions

PROCEDUREzygomatic 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

No masking is used. Both the surgeon and participant are aware of the intervention.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Bone density around zygomatic implants6 months postoperativelyBone density measured using Cone Beam Computed Tomography (CBCT) and expressed in Hounsfield Units (HU)

Secondary

MeasureTime frameDescription
secondary stability of zygomatic implants6 months postoperativelyImplant stability measured using Resonance Frequency Analysis (RFA) device (Osstell) and expressed as Implant Stability Quotient (ISQ)

Countries

Egypt

Contacts

CONTACTTilal Sidahmed Ahmed, BDS
Tilal.sidahmed@dentistry.cu.edu.eg00201555225441
CONTACTWalaa Kadry Hafez, Associate professor of OMFS
walaakadry@dentistry.cu.edu.eg00201061527359
PRINCIPAL_INVESTIGATORRamy Ragab Elbeialy, Professor of OMFS

Cairo University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 1, 2026