SURGICAL GUIDES EFFECTIVENESS
ConditionAtrophic Maxilla
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversidad Complutense de Madrid
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Smoking (more than 10 cigarettes per day).
Alcoholism (more than 25g/day in women and more than 40g/day in men according to WHO criteria),
Oncological treatment (history of treatment in the last 6 months or current treatment with chemotherapy or radiotherapy).
History of head and neck radiotherapy.
Trial design
Design model
Parallel
Treatments tested in this trial
Surgical Guide
Procedure/SurgeryPlacing extralarge implats for rahabilitation atrophic maxilla
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Guide Surgery ArmExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov