SURGICAL GUIDES EFFECTIVENESS (ASG-EI)

PRECISION OF SURGICAL GUIDES FOR PLACEMENT OF EXTRA-LARGE DENTAL IMPLANTS. A PILOT STUDY

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.

Study Overview

• Status: Recruiting
• Conditions: Atrophic Maxilla
• Intervention / Treatment: Procedure: Surgical Guide

Detailed Description

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:

• To compare the magnitude of variations depending on implant length by superimposing postoperative CT scans using 3DSlicer® (http://www.slicer.org) and exocad® software.
• To compare the magnitude of the variations depending on the location of the implant by superimposing postoperative and postoperative CT scans using 3DSlicer® (http://www.slicer.org) and exocad® software.
• To assess the clinical relevance of cogomatic implant placement using guided surgical splinting on pain parameters and surgical time.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jesus Torres, PhD; Phone Number: 653050071; Email: jesus.torres@ucm.es

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Jesus
    • Contact: Jesus Torres, PhD
  • Madrid, Spain, 28040
    • Recruiting
    • UCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

• 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.
• Allergic to anesthetics or antibiotics.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guide Surgery Arm; Use of Surgical Guide	Procedure: Surgical Guide; Placing extralarge implats for rahabilitation atrophic maxilla
Placebo Comparator: Control; Hand Free Implant Placement	Procedure: Surgical Guide; Placing extralarge implats for rahabilitation atrophic maxilla

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Investigators: Principal Investigator: JEsus Torres, PhD, UCM

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2024
• Primary Completion (Estimated): June 12, 2025
• Study Completion (Estimated): October 12, 2025

Study Registration Dates

• First Submitted: November 30, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: C.I. 24/728-E

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No