- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07657026
Assessment of Bone Density Following Application of BMAC Around Zygomatic Implant (BMAC)
Assessment of Bone Density Following Application of Bone Marrow Aspirate Concentrate Around Zygomatic Implants (Via the Intrasinus Approach): A Case Series Study
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Tilal Sidahmed Ahmed, BDS
- Telefonnummer: 00201555225441
- E-post: Tilal.sidahmed@dentistry.cu.edu.eg
Studer Kontakt Backup
- Navn: Walaa Kadry Hafez, Associate professor of OMFS
- Telefonnummer: 00201061527359
- E-post: walaakadry@dentistry.cu.edu.eg
Studiesteder
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Cairo Governate
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Cairo, Cairo Governate, Egypt, 11562
- Faculty of Dentistry, Cairo University , Department of Oral and Maxillofacial Surgery
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: zygomatic implant group
All eligible participants with atrophied maxilla receiving zygomatic implant placement for fixed prosthetic rehabilitation.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Bone density around zygomatic implants
Tidsramme: 6 months postoperatively
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Bone density measured using Cone Beam Computed Tomography (CBCT) and expressed in Hounsfield Units (HU)
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6 months postoperatively
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
secondary stability of zygomatic implants
Tidsramme: 6 months postoperatively
|
Implant stability measured using Resonance Frequency Analysis (RFA) device (Osstell) and expressed as Implant Stability Quotient (ISQ)
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6 months postoperatively
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Ramy Ragab Elbeialy, Professor of OMFS, Cairo University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- omfs3-3-20-
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Individual participant data will not be shared due to ethical restrictions and patient privacy regulations.
IPD will be shared after publication.
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