Buccal Fat Pad vs. Palatal Rotation Scarf Grafts for Soft Tissue Management Around Zygomatic Implants: A Randomized Clinical Trial

Not Applicable

Not yet recruiting

• Conditions: Soft Tissue Healing; Zygomatic Implants; Atrophic Maxilla; Soft Tissue Defect

• Registration Number: NCT06968780
• Lead Sponsor: Cairo University

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.

Detailed Description

The study aims to compare two different soft tissue augmentation techniques-buccal fat pad graft and palatal rotation scarf graft-to determine which method is more effective in enhancing soft tissue volume, improving tissue stability, and preventing dehiscence around zygomatic implants. Both grafts have shown promise in separate clinical applications, but this head-to-head comparison it will help in identifying the more optimal and predictable graft technique, the research aims to improve clinical outcomes, reduce complications, and enhance the long-term success of zygomatic implants in challenging clinical scenarios.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-05
• Study First Submitted QC: 2025-05-05
• Last Update Submitted: 2025-05-05
• Study First Posted: 2025-05-13
• Last Update Posted: 2025-05-13
• Study Start: 2025-06-20
• Primary Completion: 2026-03-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1. Patient of age 18 years or more, who can understand and sign an informed consent.
2. Patients with severely atrophic edentulous upper arch (Cawood & Howell class IV, V, VI) that could not be restored by standard axial implants without augmentation.
3. 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.
4. Good systemic health (ASA score I-II)
5. Highly motivated patients with good compliance to oral hygiene habits.

Exclusion Criteria

1. 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).
2. Patients with conditions contraindicating implant placement (e.g.: radiation to the head and neck, intra-venous bisphosphonates, uncontrolled Diabetes mellitus).
3. Heavy smokers. (> 20 cigarettes daily)
4. Patient with psychiatric problems, severe bruxism, or other parafunctional habits.
5. Acute maxillary sinus infection or untreated maxillary sinus cyst.
6. Malignancy or pathology in Maxilla or Zygoma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Peri-implant Soft-Tissue Recessions (PSTR), Condition & Quality	6 months	Incidence of dehiscence and peri-implantitis based on clinical examination, reference photographs obtained, signs of infection, keratinized soft tissue thickness using periodontal probe.

Secondary Outcome Measures

Name	Time	Method
Implant Survival Rate	6 months	ORIS Success Criteria of Zygomatic Implants

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Giza, Egypt