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

May 18, 2026 updated by: Mohamed Safwat Abdelhamed, Future University in Egypt

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: waleed fathy associate professor of oral and maxillofacial surgery at FUE, associate professor of oral an
  • Phone Number: 002 +20 10 06614712
  • Email: waleed.fathy@fue.edu.eg

Study Contact Backup

  • Name: aya magdy lecturer of oral and maxillofacial surgery at FUE, LECTURER
  • Phone Number: 002 00201000252400
  • Email: Aya.magdy@fue.edu.eg

Study Locations

  • Egypt
    • New Cairo
      • Cairo, New Cairo, Egypt, 11835
        • Recruiting
        • Future university in egypt
        • Contact:
          • lobna abdelaziz head of department of oral and maxillofacial surgery at FUE, professor
          • Phone Number: 00201099925769
          • Email: laziz@fue.edu.eg
        • Principal Investigator:
          • mohamed abdelhamid maarouf eid, bachelor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
Active Comparator: Buccal fat pad coverage over zygomatic implant from the buccal side
Procedure: covering zygomatic implants using buccal fat pad
covering the exposed part of the zygomatic implant using buccal fat pad from the buccal side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Future University in Egypt

Investigators

  • Study Director: ahmed abozekry, associate professor, oral and maxillofacial surgery at FUE
  • Principal Investigator: omar magdy el awady, bachelor
  • Study Chair: Ramy Ragab El beialy, Professor, Cairo university in egypt oral and maxillofacial department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

April 6, 2026

First Submitted That Met QC Criteria

May 4, 2026

First Posted (Actual)

May 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUE.REC(87)/11-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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