SURGICAL GUIDES EFFECTIVENESS (ASG-EI)

Universidad Complutense de Madrid

Status: Enrolling

Conditions: Atrophic Maxilla

Treatments: Procedure: Surgical Guide

Study type: Interventional

Funder types: Other

Identifiers

NCT06737289

C.I. 24/728-E

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Guide Surgery Arm

Experimental group

Description:

Use of Surgical Guide

Treatment:

Procedure: Surgical Guide

Control

Placebo Comparator group

Description:

Hand Free Implant Placement

Treatment:

Procedure: Surgical Guide