Assessment of Bone Density Following Application of BMAC Around Zygomatic Implant

ConditionSevere Maxillary Atrophy

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorCairo University

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

zygomatic implants placement
Procedure/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.

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: zygomatic implant groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Bone density around zygomatic implants

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

Time frame

6 months postoperatively

Secondary outcomes

secondary stability of zygomatic implants

Implant stability measured using Resonance Frequency Analysis (RFA) device (Osstell) and expressed as Implant Stability Quotient (ISQ)

Time frame

6 months postoperatively

Sponsors and contacts

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Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: