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RecruitingNCT07574606Updated May 20, 2026

Assessment of Soft Tissue Thickness Over Zygomatic Implants in Atrophied Maxilla Covered With Buccal Fat Pad vs. Palatal Pedicle Flap

An interventional study of Palatal pedicle over zygomatic implant and covering zygomatic implants using buccal fat pad in Atrophic Edentulous Maxilla, Zygomatic Implants and Dental Implant, sponsored by Future University in Egypt. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-20.

Sponsored by Future University in Egypt · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Registered 5 months after the study started (first participant enrolled Nov 2025, registered Apr 2026).
  • Started Nov 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Background and Rationale The rehabilitation of the severely atrophied maxilla utilizing zygomatic implants is a highly predictable and effective treatment modality. However, managing the peri-implant soft tissue in these complex cases remains a significant clinical challenge. Because zygomatic implants frequently emerge through thin, non-keratinized, and mobile alveolar mucosa rather than thick, attached gingiva, the peri-implant environment is highly susceptible to complications. Inadequate soft tissue thickness can lead to mucosal recession, exposure of the implant collar, plaque accumulation, and ultimately peri-implantitis, which threatens the long-term success of the prosthesis.

To mitigate these risks and achieve an optimal permucosal seal, soft tissue augmentation is often required. Vascularized soft tissue grafts are preferred in these compromised anatomical sites due to their robust blood supply and enhanced healing capacity. The Buccal Fat Pad (BFP) flap is a well-documented and frequently utilized technique for this purpose; however, its volume can be unpredictable, and it may be unavailable due to prior surgeries or anatomical deficiencies. Therefore, evaluating robust alternatives, such as the Palatal Pedicle Flap (PPF)-which utilizes the thick, keratinized palatal mucosa-is critical for optimizing surgical outcomes.

Study Design and Methodology This study is structured as a prospective, randomized controlled clinical trial utilizing a split-mouth design. The split-mouth approach is strategically chosen to eliminate inter-subject biological and immunological variability, allowing each patient to effectively serve as their own control. Patients presenting with a severely resorbed maxilla requiring bilateral zygomatic implant placement will be enrolled.

Following successful implant placement, the right and left maxillary quadrants will be randomized. One side will be assigned to receive soft tissue augmentation using the standard Buccal Fat Pad (BFP) flap, while the contralateral side will be assigned to receive the Palatal Pedicle Flap (PPF).

Surgical Intervention Overview All surgical procedures will be performed under appropriate anesthesia following standard sterile protocols.

For the BFP side: The buccal fat pad will be accessed via a vestibular mucosal incision, carefully bluntly dissected, mobilized, and advanced over the zygomatic implant collar without tension.

For the PPF side: A palatal pedicle flap will be meticulously outlined, elevated with its vascular supply intact, rotated, and adapted around the contralateral implant collar.

Both flaps will be secured using appropriate resorbable sutures to ensure tension-free primary closure and optimal tissue adaptation around the implant abutment interface. Post-operative care will adhere to standard institutional guidelines, including the prescription of appropriate analgesics, antibiotics, and antimicrobial mouth rinses.

Clinical Significance By systematically comparing the healing trajectories, tissue stability, and functional outcomes of the BFP and PPF techniques over a 6-month period, this trial aims to provide definitive, evidence-based guidance for soft tissue management in zygomatic implantology. Furthermore, it seeks to validate the PPF as a reliable and predictable reconstructive alternative in clinical scenarios where the buccal fat pad is deemed insufficient or inaccessible.

02

Conditions studied

  • Atrophic Edentulous Maxilla
  • Zygomatic Implants
  • Dental Implant
  • Soft Tissue Augmentation at Dental Implants
  • Soft Tissue Coverage
  • Buccal Fat Pad
  • Palatal Pedicle Flap
  • Zygomatic Implant Recession

Keywords

  • atophic edentulous maxilla
  • zygomatic implants
  • dental implants
  • soft tissue augmentation at dental implant site
  • soft tissue coverage
  • buccal fat pad
  • palatal pedicle flap
  • zygomatic implant recession
03

In context

Lead sponsor

Future University in Egypt is the lead sponsor of 97 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
4 participants (estimated)

Study arms

  • Active comparator
    Palatal pedicle flap coverage over zygomatic implant

    a palatal pedicle is scored from the palatal mucosa with the greater palatine artery and is rotated to cover the zygomatic implant at the area of the zygomatic implant collar/zaga critical zone. From the palatal side

    Procedure: Palatal pedicle over zygomatic implant

  • Active comparator
    Buccal fat pad coverage over zygomatic implant from the buccal side

    Buccal fat pad coverage over zygomatic implant from the buccal side

    Procedure: covering zygomatic implants using buccal fat pad

Interventions

  • ProcedurePalatal pedicle over zygomatic implant

    a palatal pedicle is scored from the palatal mucosa with the greater palatine artery and is rotated to cover the zygomatic implant at the area of the zygomatic implant collar/zaga critical zone. From the palatal side

  • Procedurecovering zygomatic implants using buccal fat pad

    covering the exposed part of the zygomatic implant using buccal fat pad from the buccal side.

06

What researchers measure

Primary outcomes

  1. Soft tissue thickness over the implant collar measured using a periodontal probe at 3 points on the buccal, surface mesial and distal to the implant platform.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Future University in Egypt
    Cairo, New Cairo 11835, Egypt
    • lobna abdelaziz head of department of oral and maxillofacial surgery at FUE, professor · Contact · laziz@fue.edu.eg · 00201099925769
    • mohamed abdelhamid maarouf eid, bachelor · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07574606
Lead sponsor
Future University in Egypt
Responsible party
Mohamed Safwat Abdelhamed (Principal investigator, Future University in Egypt) — Principal investigator
First posted
May 8, 2026
Start date
Nov 3, 2025
Primary completion
Jun 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
May 20, 2026

Study contacts

waleed fathy associate professor of oral and maxillofacial surgery at FUE, associate professor of oral an
Contact
waleed.fathy@fue.edu.eg
+20 10 06614712 ext. 002
aya magdy lecturer of oral and maxillofacial surgery at FUE, LECTURER
Contact
Aya.magdy@fue.edu.eg
00201000252400 ext. 002
ahmed abozekry, associate professor
study director · oral and maxillofacial surgery at FUE
omar magdy el awady, bachelor
principal investigator
Ramy Ragab El beialy, Professor
study chair · Cairo university in egypt oral and maxillofacial department

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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