Accuracy of Metal Sleeve-Free Fully Guided Implant Surgery
ConditionEdentulism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad Complutense de Madrid
About this trial
This clinical trial aims to evaluate the in vivo accuracy of fully guided dental implant surgery using 3D-printed surgical guides without metal sleeves. The study is designed as a split-mouth clinical trial and will be conducted in partially or fully edentulous adult patients requiring complete-arch rehabilitation with dental implants.
The primary objective of the study is to assess the accuracy of implant placement by comparing the virtually planned implant positions with the actual clinical positions achieved after guided surgery. Accuracy will be evaluated by analyzing linear and angular deviations between planned and placed implants.
Participants will undergo a fully guided implant placement procedure using metal sleeve-free surgical guides. Two different drilling channel diameters (standard and reduced) will be randomly assigned in a split-mouth manner. Postoperative intraoral scans and cone-beam computed tomography (CBCT) scans with scan bodies will be obtained to register the final implant positions.
The planned and achieved implant positions will be compared using three-dimensional analysis software to quantify deviations and determine whether the use of metal sleeve-free guides and reduced drilling diameters influences implant placement accuracy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Partially or fully edentulous patients requiring fixed complete-arch rehabilitation with dental implants.
Patients classified as ASA I or ASA II.
Adult patients aged 18 years or older.
Ability to understand the study procedures and provide written informed consent.
Disqualifiers
Patients classified as ASA III or ASA IV.
Patients with medical conditions that contraindicate dental implant surgery.
Inability or unwillingness to provide informed consent.
Trial design
Design model
Crossover
Treatments tested in this trial
Standard Drilling Channel Metal Sleeve-Free Surgical Guide
DeviceFully guided dental implant surgery performed using 3D-printed surgical guides without metal sleeves. The guides are designed based on virtual implant planning and used to place dental implants with a standard drilling channel diameter in a split-mouth design.
Reduced drilling channel Metal Sleeve-Free Surgical Guide
DeviceFully guided dental implant surgery performed using 3D-printed surgical guides without metal sleeves. The guides are designed based on virtual implant planning and used to place dental implants with reduced drilling channel diameter in a split-mouth design.
Treatment groups
15 Participants
are divided into 2 treatment groupsGroup A: Standard Drilling DiameterExperimental treatment 1 intervention
Group B: Reduced Drilling DiameterExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Effect of Drilling Channel Diameter on Implant Placement Accuracy
Implant placement accuracy will be compared between implants placed using fully guided surgical guides with a standard drilling channel diameter (4.85 mm) and those placed using a reduced drilling channel diameter (4.83 mm). Linear deviations at the coronal and apical implant levels, as well as angular deviations of the implant axis, relative to the virtual implant planning will be measured to determine whether differences in accuracy exist between both drilling conditions.
Time frame
Immediately after implant placementSecondary outcomes
1
Deviation Between Planned and Actual Implant Positions
The linear and angular deviations between the virtually planned implant positions and the actual implant positions achieved after fully guided implant surgery will be evaluated to describe overall implant placement accuracy.
Time frame
Immediately after implant placementSponsors and contacts
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Source ClinicalTrials.gov