Buccal Fat Pad vs. Palatal Rotation Scarf Grafts for Soft Tissue Management Around Zygomatic Implants

NCT06968780 | Recruiting DMC

• 1 other identifier: ZYGO-RCT-BFPvsPRG-2025
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Over the past 20 years, the demand for oral rehabilitation among edentulous patients has steadily increased. Traditionally, individuals with edentulous maxillae were treated using removable complete dentures. However, these often result in poor patient satisfaction due to instability and functional limitations. Dental rehabilitation with implants in the maxillary arch presents unique challenges, primarily due to the anatomical complexity of the maxilla and the need for adequate residual ridge dimensions for successful implant placement. Following the extraction of maxillary teeth, patients experience rapid and progressive alveolar bone loss in both vertical and horizontal dimensions. This resorption is largely attributed to the absence of teeth and periodontal ligament fibers support, which are essential for transmitting mechanical forces that maintain bone homeostasis. In addition, the loss of maxillary molars accelerates pneumatization/expansion of the maxillary sinus, further reducing available bone volume. Contributing factors such as ill-fitting dentures and systemic health conditions can exacerbate this process, complicating implant placement even further. To overcome these limitations, oral and maxillofacial surgeons have developed a range of advanced techniques, including tilted implants, sinus floor elevation, short implants, pterygoid implants, and most notably, zygomatic implants. Zygomatic implants bypass the atrophic alveolar ridge entirely by anchoring into the dense zygomatic bone, offering a reliable solution for patients with severely resorbed maxillae who are not candidates for conventional implant therapy.

Conditions

Zygomatic Implants; Soft Tissue Defect; Soft Tissue Healing; Atrophic Maxilla

Keywords

ZAGA; Zygomatic Implants; Buccal Fat Pad; BFP; Palatal Rotation Graft; PRG; Scarf Graft; Atrophic Maxilla; Soft tissue Recession; Dehiscence; RCT; Zygoma; Implant

Outcome Measures

Primary Outcomes (1)

• Peri-implant Soft-Tissue Recessions (PSTR), Condition & Quality

  Incidence of dehiscence and peri-implantitis based on clinical examination, reference photographs obtained, signs of infection, keratinized soft tissue thickness using periodontal probe.

  6 months

Secondary Outcomes (1)

• Implant Survival Rate

  6 months

Study Arms (2)

Zygomatic implants placed using ZAGA approach & Buccal Fat Pad

EXPERIMENTAL

All patients involved in this study will be divided into two groups, each group will receive Zygomatic implants (Exteriorized ZAGA approach) alone (dual bilateral, quad) or in combination with axial implants if bone permits(hybrid). The first group (Control Group) will be treated with the buccal pad of fat graft, while the other (Study Group) is going to be treated by the palatal scarf graft after implant placement. BFP has a long successful history in oral surgery for its use in closure of Oroantral communication and taking advantage of the fact that it contains progenitor stem cells showing similar phenotype with (ASC) adipose-derived stem cells characteristics, which can similarly differentiate into the chondrogenic, adipogenic, or osteogenic lineage. Making them an invaluable reservoir for tissue engineering.

Procedure: Buccal Fat Pad

Zygomatic implants placed using ZAGA approach & Palatal Rotation Scarf Graft

EXPERIMENTAL

All patients involved in this study will be divided into two groups, each group will receive Zygomatic implants (Exteriorized ZAGA approach) alone (dual bilateral, quad) or in combination with axial implants if bone permits(hybrid). The first group (Control Group) will be treated with the buccal pad of fat graft, while the other (Study Group) is going to be treated by the palatal scarf graft after implant placement. This technique uses tissue from the palatal area, which has a rich blood supply placed around the neck of the zygomatic implant aiming to protect the mucosal tissues buccal to the exteriorized implants from capillary compression and subsequent soft tissue recession. The palatal rotation scarf graft has been proven to provide a robust, resilient soft tissue flap with good potential for long-term stability and esthetic outcomes around implants

Procedure: Palatal Rotation Scarf Graft

Interventions

Buccal Fat Pad PROCEDURE

BFP has a long successful history in oral surgery for its use in closure of Oroantral communication and taking advantage of the fact that it contains progenitor stem cells showing similar phenotype with (ASC) adipose-derived stem cells characteristics, which can similarly differentiate into the chondrogenic, adipogenic, or osteogenic lineage. Making them an invaluable reservoir for tissue engineering.

Also known as: Buccal pad of fat, BFP

Zygomatic implants placed using ZAGA approach & Buccal Fat Pad

Palatal Rotation Scarf Graft PROCEDURE

This technique uses tissue from the palatal area, which has a rich blood supply placed around the neck of the zygomatic implant aiming to protect the mucosal tissues buccal to the exteriorized implants from capillary compression and subsequent soft tissue recession. The palatal rotation scarf graft has been proven to provide a robust, resilient soft tissue flap with good potential for long-term stability and esthetic outcomes around implants.

Also known as: Scarf Graft, Palatal pedicled graft, Palatal graft flap

Zygomatic implants placed using ZAGA approach & Palatal Rotation Scarf Graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient of age 18 years or more, who can understand and sign an informed consent.
• Patients with severely atrophic edentulous upper arch (Cawood \& Howell class IV, V, VI) that could not be restored by standard axial implants without augmentation.
• Patients with severely atrophic edentulous upper arch (Bedrossian classification inadequate bone in zones II or III or all three zones) that could not be restored by standard axial implants without augmentation.
• Good systemic health (ASA score I-II)
• Highly motivated patients with good compliance to oral hygiene habits.

You may not qualify if:

• Patients with cardiovascular disease or pulmonary disease or medical systemic condition that does not permit the surgical procedure under general anesthesia (ASA III, IV, V and VI).
• Patients with conditions contraindicating implant placement (e.g.: radiation to the head and neck, intra-venous bisphosphonates, uncontrolled Diabetes mellitus).
• Heavy smokers. (\> 20 cigarettes daily)
• Patient with psychiatric problems, severe bruxism, or other parafunctional habits.
• Acute maxillary sinus infection or untreated maxillary sinus cyst.
• Malignancy or pathology in Maxilla or Zygoma.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 12613, Egypt

RECRUITING

Related Publications (1)

• Blanco-Ruiz S, Molinero-Mourelle P, Blanco-Ruiz M, Fernandez-Tresguerres FG, Blanco-Samper S, Lopez-Quiles J. Effect of the buccal fat pad in the prevention of zygomatic implant surgery postoperative complications: A pilot study. Med Oral Patol Oral Cir Bucal. 2023 Jul 1;28(4):e371-e377. doi: 10.4317/medoral.25792.

  PMID: 37330966 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Atrophic Maxilla

Interventions

2-benzyl-3-formylpropanoic acid

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Maxillary Diseases; Jaw Diseases; Stomatognathic Diseases

Study Officials

• Ramy R El-Beialy, PhD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Khaled M Allam, DDS

CONTACT

+201122189816; khaled-allam@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Each patient will be given a code by the researcher and the observers will be blind to which group this case belong. Patients, radiographic outcome assessor and statistician will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 1. Superiority test. 2. Randomized Controlled Clinical Trial. 3. Parallel group study. 4. Allocation Ratio 1:1.

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

EG (1)