Severe Maxillary AtrophyBMACNCT07657026
Assessment of Bone Density Following Application of BMAC Around Zygomatic Implant
A study testing zygomatic implants placement in people with Severe Maxillary Atrophy, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Maxillary Atrophy
- What is being tested?
- zygomatic implants placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2026to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Patients taking contraindicated drugs such as bisphosphonates.
- Patients with sinus pathology or acute sinusitis.
- Patients with malignancy or pathology of maxilla.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dentistry, Cairo University , Department of Oral and Maxillofacial Surgery
Cairo, Cairo Governate, 11562
About this study
Official title: 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)
Read the 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.
- Conditions
- Severe Maxillary Atrophy
- Being tested
- zygomatic implants placement
- Keywords
- zygomatic implants, Bone marrow aspirate concentrate, Bone density, CBCT, Intrasinus approach, Mesenchymal stem cells, Osseointegration, Secondary stability
- Medical subject headings
- Atrophic Maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zygomatic implants placementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| zygomatic implant group | Experimental | All eligible participants with atrophied maxilla receiving zygomatic implant placement for fixed prosthetic rehabilitation. Receives: Procedure: zygomatic implants placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density around zygomatic implants
Bone density measured using Cone Beam Computed Tomography (CBCT) and expressed in Hounsfield Units (HU)
Measured: 6 months postoperatively
Secondary outcomes (1)
secondary stability of zygomatic implants
Implant stability measured using Resonance Frequency Analysis (RFA) device (Osstell) and expressed as Implant Stability Quotient (ISQ)
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Maxillary AtrophyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive zygomatic implants with bone marrow aspirate concentrate (BMAC) loaded on gelatine sponge around the implants via intrasinus approach
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tilal Sidahmed Mohamed Ahmed, Cairo University
- Investigators
- Ramy Ragab Elbeialy, Professor of OMFS, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657026
- Sponsor's protocol ID
- omfs3-3-20-
- Acronym
- BMAC
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical restrictions and patient privacy regulations. IPD will be shared after publication.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bone Density Following Application of Bone Marrow Aspirate Concentrate Around Zygomatic Implants (Via the Intrasinus Approach): A Case Series Study
- ClinicalTrials.gov ID
- NCT07657026
- Acronym / sponsor ID
- BMAC / omfs3-3-20-
- Conditions
- Severe Maxillary Atrophy
- Keywords
- zygomatic implants, Bone marrow aspirate concentrate, Bone density, CBCT, Intrasinus approach, Mesenchymal stem cells, Osseointegration, Secondary stability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive zygomatic implants with bone marrow aspirate concentrate (BMAC) loaded on gelatine sponge around the implants via intrasinus approach
| Arm | Type | Receives |
|---|---|---|
| zygomatic implant group | Experimental | Procedure: zygomatic implants placementAll eligible participants with atrophied maxilla receiving zygomatic implant placement for fixed prosthetic rehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zygomatic implants placementplacement 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. | Procedure or surgery | zygomatic implant group |
Primary outcome
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)
1 secondary outcome
secondary stability of zygomatic implants
Time frame: 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical restrictions and patient privacy regulations. IPD will be shared after publication.
Related trials for Severe Maxillary Atrophy
Recruiting
Two-Stage Transcrestal Sinus Lift With Osseodensification: Allograft vs Autogenous-Xenograft
Severely Atrophic Posterior Maxilla
RecruitingPhase 2/3
Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation
Maxillary Sinus Floor Augmentation, Maxillary Sinus Elevation
Recruiting
Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Static Surgical Guides in Severely Atrophic Maxilla
Atrophic Edentulous Maxilla, Zygomatic Implants
Recruiting
Buccal Fat Pad vs. Palatal Rotation Scarf Grafts for Soft Tissue Management Around Zygomatic Implants
Zygomatic Implants, Atrophic Maxilla
Not yet recruiting
NobelZygoma TiUltra Implant System Study
Edentulous Maxilla, Maxillary Bone Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ramy Ragab Elbeialy, Professor of OMFS principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zygomatic implants placement in people with Severe Maxillary Atrophy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tilal Sidahmed Ahmed, BDS (00201555225441, Tilal.sidahmed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone density around zygomatic implants (time frame: 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.