Buccal fat pad versus palatal pedicle flap for soft tissue coverage over zygomatic implants in a severely atrophied upper jaw
Assessment of Soft Tissue Thickness Over Zygomatic Implants in Atrophied Maxilla Covered With Buccal Fat Pad vs. Palatal Pedicle Flap
This trial will test whether using the buccal fat pad or a palatal pedicle flap gives thicker, more stable soft tissue around zygomatic implants in adults with a severely atrophied upper jaw.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 4 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Future University in Egypt Academic / other |
| Locations | 1 site (Cairo, New Cairo) |
| Trial ID | NCT07574606 on ClinicalTrials.gov |
What this trial studies
This interventional trial compares two vascularized soft tissue techniques—the buccal fat pad flap and the palatal pedicle flap—for covering zygomatic implants placed in patients with severely atrophic maxillae. Adult patients eligible for zygomatic implant–supported fixed prostheses will be enrolled at Future University in New Cairo and assigned to one of the two coverage procedures. Primary outcomes include soft tissue thickness over the implant collars, mucosal stability, and complication rates such as dehiscence, implant exposure, or need for additional interventions, measured over postoperative follow-up. The trial aims to identify which flap provides better long-term soft tissue health around trans-mucosal zygomatic implants.
Who should consider this trial
Good fit: Adults (≥18) with severely atrophic maxillae indicated for zygomatic implant–supported fixed prostheses who can tolerate surgery and attend follow-up visits are ideal candidates.
Not a fit: Patients with uncontrolled systemic disease, heavy smoking, prior radiotherapy or bisphosphonate therapy, active sinus infection, severe parafunctional habits, pregnancy, or psychiatric conditions affecting compliance are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the preferred flap could reduce implant exposure and peri-implant disease by creating a thicker, well-vascularized soft tissue seal and improve long-term success of zygomatic prostheses.
How similar studies have performed: Both the buccal fat pad and palatal pedicle flap are well-documented for oral soft tissue reconstruction, but direct comparative data specifically for covering zygomatic implants are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients ≥18 years with severely atrophic maxilla. * Acquired maxillary defects resulting from trauma, pathology, or previous surgical resection. * Indicated for zygomatic implant-supported fixed prosthesis. * Sufficient mouth opening for zygomatic implants placement. * Patients willing to sign informed consent and attend follow-ups. Exclusion Criteria: * Uncontrolled systemic disease affecting healing (e.g., uncontrolled diabetes, etc). * Heavy smokers * Previous radiotherapy or bisphosphonate therapy. * Active sinus or nasal infection. * Severe parafunctional habits (e.g., bruxism). * Pregnant or lactating women. * Patients with psychiatric disorders affecting compliance.
Where this trial is running
Cairo, New Cairo
- Future University in Egypt — Cairo, New Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: omar magdy el awady, bachelor
- Study coordinator: waleed fathy associate professor of oral and maxillofacial surgery at FUE, associate professor of oral an
- Email: waleed.fathy@fue.edu.eg
- Phone: +20 10 06614712
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.