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NCT Number: NCT07562334

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

Would buccal pad of fat be comparable to platelet rich fibrin for Zygomatic implant coverage as a step for reconstruction of atrophic posterior maxilla, in terms of peri-implant soft tissue thickness and avoiding complicated postoperative sequalae?

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo university, Faculty of dentistry

Cairo, Cairo Governorate, 11562, Egypt

Location status: Recruiting

Location contact

CONTACT

01223617956

About this study

This study aims to assess whether the buccal fat pad might prevent mucosal dehiscence and avoid potential postoperative complications when buccal fat pad is used to cover the body part of the zygomatic implants compared to the platelet rich fibrin during the reconstruction of atrophic maxilla. The expected benefit from the current study is to select the most suitable coverage for Zygomatic implant placement with the least postoperative complications also providing an appropriate soft tissue profile during the immediate loading phase preparing it for the final restoration.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Coverage with PRF for Zygomatic implant placed

Biological

PRF preparation and placement: Shortly before being positioned at the surgical site, the PRF was freshly prepared. Ten milliliters of blood were extracted from the antecubital vein and put into a test tube devoid of anticoagulant for the PRF preparation. The blood sample was centrifuged right away for 10-12 minutes at 3000 rpm. The PRF membrane was obtained by squeezing the fibrin clot between pieces of gauze after centrifugation

Primary outcomes

  1. The peri-implant soft tissue thickness

    Time frame: Clinical evaluation will be performed at the operation day, 72 hours, 1st week, 15 days, 1month, 4-month intervals will be the first assessment for the soft tissue thickness then at 6 months and 12 months interval.

    The peri-implant soft tissue thickness using the average of three measurement points on the buccal side of the implant platform registered with a periodontal probe (HH12 periodontal probe, Deppeler SA)

Secondary outcomes

  1. Postoperative complications

    Time frame: Clinical evaluation will be performed at the operation day, 72 hours, 1st week, 15 days, 1month, 4-month intervals will be the first assessment for the soft tissue thickness and postoperative complications then at 6 months and 12 months interval.

    Recording of frequency and Incidence of Zygomatic fracture/oroantral communication/implant failure

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline John Caroline John George, masters

CONTACT

[email protected]

+201282101184

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 1, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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