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Phase Not Applicable
All Genders
ID07562334

Assessment of Soft Tissue Thickness Using Buccal Pad of Fat Versus Platelet-rich Fibrin for Covering Zygomatic Implants: A Randomized Clinical Trial

Led by Cairo University · Updated on 2026-05-01

24

Participants Needed

1

Research Sites

12 weeks

Total Duration

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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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

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

AI-Screening

AI-Powered Screening

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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)

Trial Site Locations

Total: 1 location

1

Cairo university, Faculty of dentistry

Cairo, Cairo Governorate, Egypt, 11562

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Research Team

C

Caroline John Caroline John George, masters

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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Published Research Related To This Trial

Effect of the buccal fat pad in the prevention of zygomatic implant surgery postoperative complications: A pilot study.

S Blanco-Ruiz, P Molinero-Mourelle, M Blanco-Ruiz...

https://pubmed.ncbi.nlm.nih.gov/37330966

Use of Platelet-Rich Fibrin Membranes With Single Implant Placement for Peri-Implant Mucosal Thickness Augmentation: A Case Series Study.

Victória Clara da Silva Lima, Manuela Maria Viana Miguel, Laís Fernanda Ferreira Ferraz...

https://pubmed.ncbi.nlm.nih.gov/33340395