Comparing Buccal Fat Pad and Platelet-rich Fibrin for Covering Zygomatic Implants to Improve Soft Tissue and Reduce Complications in Severe Upper Jaw Bone Loss
Led by Cairo University · Updated on 2026-05-01
24
Participants Needed
1
Research Sites
12 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to compare two methods for covering zygomatic implants during reconstruction of the atrophic posterior maxilla the buccal pad of fat and platelet rich fibrin PRF. The study evaluates which method better supports peri-implant soft tissue thickness and reduces postoperative complications. The goal is to identify the most suitable coverage to ensure proper soft tissue profile and minimize complications during the implant loading and final restoration phases.
Participants will receive either the buccal fat pad coverage or PRF coverage over the zygomatic implants. PRF is freshly prepared by drawing blood, centrifuging it to form a fibrin membrane, which is then placed at the surgical site. The buccal fat pad is carefully dissected and repositioned over the implant body and secured with sutures. Both procedures are performed during implant placement, with attention to careful tissue handling to avoid premature traction.
During the study, clinical evaluations will measure peri-implant soft tissue thickness and monitor postoperative complications at multiple time points the operation day, 72 hours, 1 week, 15 days, 1 month, 4 months, 6 months, and 12 months. These assessments will help determine the effectiveness and safety of each coverage method. The total participation duration lasts up to 12 months with regular follow-ups to ensure thorough monitoring and data collection.
CONDITIONS
Brief Title
Assessment of Soft Tissue Thickness Following Utilization of Buccal Pad of Fat Versus Platelet-rich Fibrin for Covering Zygomatic Implants: A Randomized Clinical Trial
Research Team
C
Caroline John Caroline John George, masters
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Patients with severely atrophic edentulous upper arch (Cawood class IV, V, VI) that cannot be restored by other treatments
Patients with at least 8-12 mm vertical bone height in anterior maxilla to allow installation of 2 conventional implants
Patients lacking posterior maxillary bone support due to significant sinus pneumatization
Good systemic health (ASA score I-II)
Highly motivated patients
You will not qualify if you...
Patients unwilling to provide informed consent
Patients with systemic diseases that prevent surgical procedures (including general anesthesia)
Patients with uncontrolled diabetes or receiving bisphosphonate therapy
Heavy smokers (more than 20 cigarettes daily)
Patients with psychiatric problems, severe bruxism, or other parafunctional habits
Patients with acute sinusitis
Patients with malignancy or pathology in maxilla or zygoma
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Surgery day plus initial recovery period
Participants undergo zygomatic implant placement covered either with the buccal fat pad or platelet-rich fibrin (PRF) to assess soft tissue thickness and reduce postoperative complications.
1 surgical visit (in-person) and follow-up visits at 72 hours, 1 week, 15 days, and 1 month
Post-operative Follow-up
Duration - Up to 12 months
Participants are monitored for soft tissue thickness and postoperative complications over time to evaluate the effectiveness of the implant coverage method.
Follow-up visits at 4 months, 6 months, and 12 months (in-person)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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