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Atrophic Edentulous MaxillaNCT07574606

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

A study testing Palatal pedicle over zygomatic implant and covering zygomatic implants using buccal fat pad in people with Atrophic Edentulous Maxilla and Zygomatic Implants, run by Future University in Egypt at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Palatal pedicle over zygomatic implant and covering zygomatic implants using buccal fat pad
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteEgypt
Study dates
3 Nov 2025to Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

waleed fathy associate professor of oral and maxillofacial surgery at FUE, associate professor of oral an contact

+20 10 06614712 ext. 002

waleed.fathy@fue.edu.eg

aya magdy lecturer of oral and maxillofacial surgery at FUE, LECTURER contact

00201000252400 ext. 002

Aya.magdy@fue.edu.eg

Egypt1 site, 1 recruiting
  • Future University in Egypt

    Cairo, New Cairo, 11835

    lobna abdelaziz head of department of oral and maxillofacial surgery at FUE, professor, 00201099925769, laziz@fue.edu.eg

    mohamed abdelhamid maarouf eid, bachelor

    Recruiting

Other trials in Egypt

About this study

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.

Read more

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.

Being tested
Palatal pedicle over zygomatic implant, covering zygomatic implants using buccal fat pad
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
Medical subject headings
Atrophic Maxilla

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Palatal pedicle over zygomatic implantProcedure or surgery

    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

  • covering zygomatic implants using buccal fat padProcedure or surgery

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

Study groups in NCT07574606
Study groupRoleWhat they receive
Palatal pedicle flap coverage over zygomatic implantActive comparatora 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
Receives: Procedure: Palatal pedicle over zygomatic implant
Buccal fat pad coverage over zygomatic implant from the buccal sideActive comparatorBuccal fat pad coverage over zygomatic implant from the buccal side
Receives: Procedure: covering zygomatic implants using buccal fat pad

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2026
  2. Study start3 Nov 2025
  3. Primary completionJun 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
12 implants in total: 6 implants covered with Palatal Pedicle Flap (Group A) 6 implants covered with Buccal Fat Pad (Group B) Intervention: After placement of zygomatic implants, soft tissue around the implant collar will be covered using either: Palatal Pedicle Flap (PPF) Buccal Fat Pad (BFP)
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
4 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07574606
Sponsor's protocol ID
FUE.REC(87)/11-2025
Status last verified
May 2026
First submitted
6 Apr 2026
Last updated
20 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Palatal pedicle over zygomatic implant and covering zygomatic implants using buccal fat pad in people with Atrophic Edentulous Maxilla and Zygomatic Implants, run by Future University in Egypt at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact waleed fathy associate professor of oral and maxillofacial surgery at FUE, associate professor of oral an (+20 10 06614712 ext. 002, waleed.fathy@fue.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.

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