Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06968780

Buccal Pad of Fat Graft vs. Palatal Rotation Scarf Graft for Soft Tissue Enhancement and Prevention of Dehiscence Around Zygomatic Implants in Patients With Severely Atrophic Maxilla

Led by Cairo University · Updated on 2025-12-12

8

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The trial investigates the use of zygomatic implants to treat patients with severely atrophic upper jaws who cannot receive standard implants due to insufficient bone. The study compares two methods of soft tissue augmentation—buccal fat pad graft and palatal rotation scarf graft—to find which better improves tissue volume, stability, and prevents soft tissue complications around these implants. This research aims to enhance long-term outcomes and reduce complications in challenging oral rehabilitation cases. Participants will receive zygomatic implants placed using the Exteriorized ZAGA approach, either alone or combined with axial implants when bone allows. They will be randomly assigned to receive one of two soft tissue grafts after implant placement: the buccal fat pad graft, known for its stem cell properties and tissue engineering potential, or the palatal rotation scarf graft, which uses well-vascularized palatal tissue to protect mucosal tissues and provide lasting stability and esthetics. During the six-month follow-up, participants will undergo assessments of soft tissue condition and quality around the implants, focusing on peri-implant soft-tissue recessions. Implant survival rates will also be monitored. The study includes regular clinical evaluations to track healing, tissue volume, and implant success, with the total participation lasting at least six months after treatment.

CONDITIONS

Brief Title

Buccal Fat Pad vs. Palatal Rotation Scarf Grafts for Soft Tissue Management Around Zygomatic Implants

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged 18 years or older who can understand and sign informed consent
  • Severely atrophic edentulous upper arch classified as Cawood & Howell class IV, V, or VI
  • Severely atrophic edentulous upper arch with inadequate bone in Bedrossian zones II, III, or all three zones
  • Good overall health with ASA score I or II
  • Highly motivated patient with good oral hygiene compliance
Not Eligible

You will not qualify if you...

  • Cardiovascular, pulmonary, or systemic conditions preventing surgery under general anesthesia (ASA III or higher)
  • Conditions contraindicating implant placement such as head/neck radiation, intravenous bisphosphonates, or uncontrolled diabetes
  • Heavy smokers (more than 20 cigarettes daily)
  • Psychiatric disorders, severe bruxism, or other parafunctional habits
  • Acute maxillary sinus infection or untreated maxillary sinus cyst
  • Malignancy or other pathology in the 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)

Treatment

Duration - Single surgical procedure with immediate soft tissue grafting

Participants undergo surgery to place zygomatic implants using the ZAGA approach combined either with a buccal fat pad graft or a palatal rotation scarf graft to enhance soft tissue around the implants and prevent tissue dehiscence.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - Up to 6 months

Participants are monitored to assess soft tissue condition, implant survival, and healing outcomes following the graft and implant placement.

Approximately 4 to 6 follow-up visits (in-person)

Trial Site Locations

Total: 1 location

1

Cairo University

Cairo, Giza Governorate, Egypt, 12613

Actively Recruiting

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Research Team

K

Khaled M Allam, DDS

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