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This clinical study aims to evaluate the effectiveness and safety of zygomatic implants placed using dynamic navigation technology. Specifically, it compares two types of zygomatic implants with different surface characteristics: one with a fully rough surface and another with a partially smooth (machined) surface near the gum line. The goal is to determine whether surface design affects surgical performance, healing, implant success, and patient outcomes. A total of 22 patients with severe upper jaw bone loss will receive both types of implants-one on each side of the upper jaw-in a randomized, split-mouth design. The study also evaluates pain, swelling, healing time, and patient quality of life over a 5-year follow-up period.
This prospective, randomized, split-mouth clinical study investigates the use of dynamic navigation for the placement of zygomatic implants in patients with severely atrophic maxillae. The primary aim is to compare two different surface configurations of zygomatic implants: a fully rough surface versus a partially machined (smooth) coronal surface. Each of the 22 enrolled patients will receive both implant types-one per side-allowing for direct intra-patient comparison.
All surgeries are planned using three-dimensional imaging and performed with a dynamic navigation system (ImplaNav), calibrated for the longer drills required for zygomatic implant sites. The study evaluates surgical accuracy, implant stability, preparation time, postoperative pain and swelling, sinus membrane response, and long-term implant and prosthetic success. Patient quality of life is also monitored over a 5-year follow-up using standardized questionnaires and radiographic assessments.
This study aims to provide evidence on whether implant surface design influences clinical performance and healing outcomes in zygomatic implant rehabilitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Rough Surface Zygomatic Implant | Active Comparator | Patients receive a zygomatic implant with a fully roughened surface (from apex to collar) on one side of the maxilla. Implant placement is performed using dynamic navigation. This arm serves as the control in a split-mouth randomized design. |
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| Modified Partially Machined Surface Zygomatic Implant | Experimental | Patients receive a zygomatic implant with a modified surface, including a smooth machined coronal portion, a non-threaded machined intermediate section, and a rough apical portion, on the contralateral side of the maxilla. Implant placement is performed using dynamic navigation. This arm represents the test condition in the split-mouth design. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rough Surface Zygomatic Implant | Device | Surgical placement of a zygomatic implant with a fully roughened surface from apex to collar. Used for the control arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| Implant Success Rate of Zygomatic Fixtures | The success of each zygomatic implant will be assessed clinically by evaluating the absence of pain, absence of mobility or rotation under contra-torque testing, and the presence of healthy peri-implant tissues. Clinical evaluation will be supported by radiographic analysis to confirm peri-implant bone maintenance and the absence of pathological signs. | 5 years after implant placement |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Site Preparation Time | Time required to prepare each zygomatic implant site will be recorded, from the start of the first drill to the complete insertion of the implant. The comparison aims to detect differences between the rough and partially machined implant groups. | Intraoperative (during implant placement) |
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Inclusion Criteria:
Patients requiring partial or full rehabilitation of the atrophic maxilla
Candidates for placement of at least one zygomatic implant per side (right and left), connected to at least one standard or zygomatic implant
Severe maxillary atrophy confirmed by CT scan, with insufficient bone for conventional implants or only sufficient bone for 2 frontal implants (minimum diameter 3.5 mm, length 8 mm)
Residual alveolar crest height ≤ 4 mm beneath the maxillary sinus
Age ≥ 18 years
Signed informed consent
Exclusion Criteria:
General contraindications to oral surgery
History of radiation therapy to the head and neck exceeding 70 Gy
Compromised or suppressed immune system
Current or past use of intravenous bisphosphonates
Uncontrolled diabetes mellitus
Alcohol or drug dependency
Psychiatric disorders
Pregnancy or breastfeeding
Participation in other clinical trials
Inability to attend a 5-year follow-up
Limited mouth opening (< 3.5 cm interincisal distance)
Absence of opposing dentition or lower prosthesis
Acute or chronic infection in the intended implant site
Untreated active periodontal disease
Poor oral hygiene motivation
Radiographic signs of sinus membrane inflammation or ostium obstruction
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27861671 | Background | Hung K, Huang W, Wang F, Wu Y. Real-Time Surgical Navigation System for the Placement of Zygomatic Implants with Severe Bone Deficiency. Int J Oral Maxillofac Implants. 2016 Nov/Dec;31(6):1444-1449. doi: 10.11607/jomi.5526. | |
| 15202664 | Background | Branemark PI, Grondahl K, Ohrnell LO, Nilsson P, Petruson B, Svensson B, Engstrand P, Nannmark U. Zygoma fixture in the management of advanced atrophy of the maxilla: technique and long-term results. Scand J Plast Reconstr Surg Hand Surg. 2004;38(2):70-85. doi: 10.1080/02844310310023918. |
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| Partially Machined Surface Zygomatic Implant | Device | Surgical placement of a modified zygomatic implant with a smooth machined coronal portion, a non-threaded machined middle section, and a rough apical portion. Used for the test arm. |
|
| Radiographic Evaluation of Peri-Implant Bone |
Assessment of peri-implant bone levels will be performed through standardized radiographs (OPT and teleradiography) and analyzed using calibrated software. Bone changes will be compared between implant types. |
| At prosthesis delivery, and at 1, 3, and 5 years post-loading |
| Peri-implant Probing Depth (PD) | Mean probing depth, in millimetres, measured circumferentially around each implant to assess peri-implant soft-tissue health. Results will be reported as mean ± SD per implant. | 1, 3, and 5 years after functional loading |
| Number of Implants with Bleeding on Probing (BOP) | Count of dental implants that exhibit bleeding upon gentle circumferential probing (≤ 0.25 N). The result will be reported as the total number of affected implants and the corresponding percentage of all implants examined at each follow-up visit. | 1, 3, and 5 years after functional loading |
| Number of Implants with Suppuration | Count of dental implants showing the presence of suppuration (pus discharge) upon gentle probing (≤ 0.25 N) during clinical examination. The result will be reported as the number and percentage of affected implants at each follow-up visit. | 1, 3, and 5 years after functional loading |
| 19821311 | Background | Esposito M, Grusovin MG, Felice P, Karatzopoulos G, Worthington HV, Coulthard P. Interventions for replacing missing teeth: horizontal and vertical bone augmentation techniques for dental implant treatment. Cochrane Database Syst Rev. 2009 Oct 7;2009(4):CD003607. doi: 10.1002/14651858.CD003607.pub4. |
| 356184 | Background | Branemark PI, Hansson BO, Adell R, Breine U, Lindstrom J, Hallen O, Ohman A. Osseointegrated implants in the treatment of the edentulous jaw. Experience from a 10-year period. Scand J Plast Reconstr Surg Suppl. 1977;16:1-132. No abstract available. |
| ID | Term |
|---|---|
| D000099066 | Atrophic Maxilla |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008439 | Maxillary Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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