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The use of zygomatic implants is a technique that is becoming more and more widespread in daily clinical practice, however, few professionals feel safe and confident in performing this type of procedure. We therefore believe that a line of research focused on simplifying this technique will have an extraordinary impact on the safety of both patients and surgeons. Currently, new surgical guides have emerged that guarantee greater precision in the placement of zygomatic implants. However, no comparative clinical studies have yet been performed to evaluate the degree of accuracy of guided implant placement compared to the conventional freehand technique.
The primary objective of the study is to study the accuracy of the use of guided surgical splints compared to traditional freehand zygomatic implant placement.
The secondary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guide Surgery Arm | Experimental | Use of Surgical Guide |
|
| Control | Placebo Comparator | Hand Free Implant Placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical Guide | Procedure | Placing extralarge implats for rahabilitation atrophic maxilla |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Surgical Guides in implant placement | Accuracy of Surgical Guides in terms of Radiological differences in implant placement. The primary outcome is to measure the differences existing between implant planificación and final implant placement. First, a computed tomography (CT) scan will be performed to plan the placement of the zygomatic implants. Once the implants have been placed in both groups, another CT scan will be performed to evaluate the following parameters using 3DSlicer® software (http://www.slicer.org). Three-dimensional lateral apical implant deviation and three-dimensional lateral neck implant deviation respect to the original digital planning will be evaluated by superimposing images. 3D lateral deviations will be measured in mm in relation with original planning. Also deviations in degrees between the original planning and the final placements will be evaluated. | 12 months |
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Inclusion Criteria:
• Age between 18-80 years of age, patients who sign the informed consent form and patients who consent to undergo preoperative and postoperative orthopantomography and CT scans.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jesus Torres, PhD | Contact | 653050071 | jesus.torres@ucm.es |
| Name | Affiliation | Role |
|---|---|---|
| JEsus Torres, PhD | UCM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jesus | Recruiting | Madrid | 28040 | Spain |
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| ID | Term |
|---|---|
| D000099066 | Atrophic Maxilla |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008439 | Maxillary Diseases |
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Split Mouth Design
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blind
| UCM | Recruiting | Madrid | 28040 | Spain |
| D007571 |
| Jaw Diseases |
| D009057 | Stomatognathic Diseases |