Buccal fat pad versus platelet-rich fibrin to cover zygomatic implants

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

We will test whether using the buccal fat pad or platelet-rich fibrin to cover zygomatic implants leads to thicker gum tissue and fewer complications for people with severely atrophic upper jaws receiving zygomatic implants.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sex: All
• Sponsor: Cairo University (other)
• Locations: 1 site (Cairo, Cairo Governorate)
• Trial ID: NCT07562334 on ClinicalTrials.gov

What this trial studies

This randomized clinical trial will compare two soft-tissue coverage techniques—buccal fat pad (BFP) and platelet-rich fibrin (PRF)—used to cover the body of zygomatic implants placed for reconstruction of a severely atrophic posterior maxilla. Eligible patients with Cawood class IV–VI edentulous upper arches and sufficient anterior bone for two conventional implants will be randomized to receive either BFP or PRF coverage at a single center. Primary outcomes include peri-implant soft tissue thickness, rates of mucosal dehiscence, and other postoperative complications measured through the immediate loading phase and up to final restoration. The trial aims to identify which coverage method provides a more stable soft tissue profile with fewer complications.

Who should consider this trial

Good fit: Ideal candidates are motivated adults with severely atrophic edentulous upper jaws (Cawood IV–VI), adequate anterior bone for two conventional implants (8–12 mm), lacking posterior maxillary support, and in good systemic health (ASA I–II).

Not a fit: Patients with uncontrolled systemic disease (including uncontrolled diabetes or current bisphosphonate therapy), heavy smokers (>20 cigarettes/day), acute sinusitis, severe bruxism or other parafunctional habits, psychiatric problems, or malignancy/pathology of the maxilla or zygoma are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, the preferred coverage method could reduce mucosal dehiscence and postoperative complications and improve soft-tissue thickness around zygomatic implants, facilitating immediate loading and final restoration.

How similar studies have performed: Both buccal fat pad and platelet-rich fibrin have been reported to improve soft tissue closure in small series, but direct randomized comparisons specifically for zygomatic implant coverage are limited.

Eligibility criteria

Inclusion Criteria:

1. Patients with severely atrophic edentulous upper arch (Cawood class IV, V, VI) that could not be restored by other type of treatment
2. Patients who had at least 8-12 mm vertical bone height in anterior maxilla to allow installation of 2 conventional implants.
3. Lacking posterior maxillary bone support due to significant sinus pneumatization
4. Good systemic health (ASA score I-II)
5. Highly motivated patients

Exclusion Criteria:

1. Patient not willing to give his/her informed consent.
2. Patients with systemic disease that did not permit the surgical procedure (including general anesthesia).
3. Patients with uncontrolled diabetes or under bisphosphonate therapy.
4. Heavy smoker. (\> 20 cigarettes daily)
5. Patient with psychiatric problems, severe bruxism or other parafunctional habits.
6. Acute sinusitis.
7. Malignancy or pathology in Maxilla or Zygoma.

Where this trial is running

Cairo, Cairo Governorate

• Cairo university, Faculty of dentistry — Cairo, Cairo Governorate, Egypt (RECRUITING)

Study contacts

• Study coordinator: Caroline John Caroline John George, masters

Conditions: Soft Tissue Augmentation at Dental Implants, evaluation of soft tissue thickness around zygomatic implants