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
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.
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.
Patients ≥18 years with severely atrophic maxilla.
Exclusion Criteria:
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
Buccal fat pad coverage over zygomatic implant from the buccal side
Procedure: covering zygomatic implants using buccal fat pad
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 the exposed part of the zygomatic implant using buccal fat pad from the buccal side.
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
Plan to share: Yes
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Atrophic Maxilla
Future University in Egypt