Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07574606

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

Led by Future University in Egypt · Updated on 2026-05-20

4

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating two methods of soft tissue coverage over zygomatic implants in patients with severely atrophied maxilla. The study aims to compare the Buccal Fat Pad flap, a common technique using vascularized soft tissue from the cheek, with the Palatal Pedicle Flap, which uses thick keratinized tissue from the palate. This randomized controlled clinical trial uses a split-mouth design where each patient receives both treatments on opposite sides to reduce variability and improve comparison accuracy. The trial involves patients with bilateral zygomatic implants placed in the upper jaw. On one side, the Buccal Fat Pad is accessed through a mucosal incision, mobilized, and secured over the implant. On the other side, the Palatal Pedicle Flap, containing its vascular supply, is rotated to cover the implant area. Both flaps are fixed with resorbable sutures for tension-free closure. Standard post-operative care, including antibiotics and mouth rinses, is provided. The healing and tissue stability will be assessed over a 6-month period. Participants will undergo evaluations of soft tissue thickness around the implant collar at three points using a periodontal probe. Post-treatment follow-ups will monitor tissue healing and implant environment stability. The study lasts 6 months, during which clinical assessments will document the outcomes of each flap technique. This trial seeks to provide reliable evidence to guide soft tissue management in complex dental implant cases where the Buccal Fat Pad may be insufficient or unavailable.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years or older with severely atrophic maxilla
  • Acquired maxillary defects from trauma, pathology, or previous surgery
  • Indicated for zygomatic implant-supported fixed prosthesis
  • Sufficient mouth opening to allow zygomatic implant placement
  • Willing to sign informed consent and attend follow-up visits
Not Eligible

You will not qualify if you...

  • Uncontrolled systemic diseases affecting healing (e.g., uncontrolled diabetes)
  • Heavy smokers
  • Previous radiotherapy or bisphosphonate therapy
  • Active sinus or nasal infection
  • Severe parafunctional habits such as bruxism
  • Pregnant or lactating women
  • Psychiatric disorders that affect compliance with the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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)

Surgery and Immediate Post-operative Care

Duration - Day of surgery plus immediate recovery period

Participants receive surgery to cover zygomatic implants using either a palatal pedicle flap or a buccal fat pad.

1 surgical visit

Post-operative Follow-up

Duration - Up to 6 months

Participants attend follow-up visits to monitor healing and assess soft tissue thickness over the implant collar.

Multiple follow-up visits over 6 months

Trial Site Locations

Total: 1 location

1

Future University in Egypt

Cairo, New Cairo, Egypt, 11835

Actively Recruiting

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Research Team

W

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

A

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

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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