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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Buccal Fat Pad

    Procedure/Surgery

    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.

  • Palatal Rotation Scarf Graft

    Procedure/Surgery

    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.

Treatment groups

8 Participants
are divided into 2 treatment groups
Group A: Zygomatic implants placed using ZAGA approach & Buccal Fat PadExperimental treatment 1 intervention
Group B: Zygomatic implants placed using ZAGA approach & Palatal Rotation Scarf GraftExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

Implant Survival Rate

ORIS Success Criteria of Zygomatic Implants

Time frame
6 months

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Cairo UniversityRecruiting12613, Cairo, Giza GovernorateEgyptEgypt

Sponsors and contacts

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