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Zygomatic Implants

Tundra lists 4 Zygomatic Implants clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.

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RECRUITING

NCT07574606

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

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.

Gender: All

Ages: 18 Years - Any

Updated: 2026-05-20

1 state

Atrophic Edentulous Maxilla
Zygomatic Implants
Dental Implant
+5
RECRUITING

NCT07551024

Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Static Surgical Guides in Severely Atrophic Maxilla

Some patients lose a large amount of bone in the upper jaw. When this happens, it can be difficult to place regular dental implants. In these cases, special implants called zygomatic implants can be used. These implants are longer than normal implants and are fixed in the cheekbone, which usually has enough bone to support them. They can help support fixed teeth for patients with severe bone loss in the upper jaw. Placing zygomatic implants requires careful planning and high accuracy. To help guide the surgeon during the operation, a surgical guide can be used. A surgical guide is a custom-made device that helps the surgeon place the implant in the planned position. Surgical guides can be made from different materials. The most common type is made from resin (a strong plastic material) using 3D printing. Recently, fully metallic surgical guides have been developed. These metal guides may be stronger and more stable during surgery, but it is not yet clear if they improve the accuracy of implant placement. The purpose of this study is to compare the accuracy of metal surgical guides and resin surgical guides when placing zygomatic implants in patients with severe bone loss in the upper jaw. Patients included in the study will undergo a clinical examination and a CT scan before surgery to plan the implant positions. During the surgery, each patient will receive zygomatic implants on both sides of the upper jaw. On one side, the implants will be placed using a metal surgical guide, and on the other side, they will be placed using a resin surgical guide. This allows the two types of guides to be compared in the same patient. After the surgery, another CT scan will be taken to check the final position of the implants. The planned implant position will be compared with the actual position after surgery to measure the accuracy of placement. The results of this study will help determine whether metallic surgical guides or resin surgical guides provide better accuracy when placing zygomatic implants. Participation in this study is voluntary. All patients will receive full information about the study and will sign a consent form before participating.

Gender: All

Ages: 18 Years - Any

Updated: 2026-05-07

1 state

Atrophic Edentulous Maxilla
Zygomatic Implants
Guided Surgery
+2
NOT YET RECRUITING

NCT07394179

Transforming Channel Osteotomy Into Tunnel Osteotomy in Zygomatic Implant Preparation

The evolution of zygomatic implant techniques, from the original procedures to the Zygomatic Anatomy-Guided Approach (ZAGA), has significantly improved outcomes for patients with severe maxillary atrophy. Despite these advancements, challenges such as peri-implant tissue recession, sinus complications, and aesthetic concerns persist. Bone augmentation and soft tissue enhancement techniques, including sinus lifts, connective tissue grafts, and buccal fat pad utilization, have been employed to address these issues with varying degrees of success. However, the need for predictable and stable bone regeneration and soft tissue contouring remains critical for long-term implant success. The following study aims to assess bone gain, soft tissue contour, and stability after using bone lamina shell, providing a potential solution to enhance peri-implant tissue integrity and optimize functional and aesthetic outcomes in zygomatic implant rehabilitation

Gender: All

Ages: 21 Years - Any

Updated: 2026-02-06

Zygomatic Implants
RECRUITING

NCT06968780

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

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.

Gender: All

Ages: 18 Years - Any

Updated: 2025-12-12

1 state

Zygomatic Implants
Atrophic Maxilla
Soft Tissue Defect
+1