SURGICAL GUIDES EFFECTIVENESS

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.

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Key information

Conditions

Atrophic Maxilla Bone Diseases Bone Resorption Jaw Diseases Maxillary Diseases Musculoskeletal Diseases Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jesus, Madrid, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgical Guide

Procedure

Placing extralarge implats for rahabilitation atrophic maxilla

Primary outcomes

Accuracy of Surgical Guides in implant placement

Time frame: 12 months

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jesus Torres, PhD

CONTACT

[email protected]

653050071

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

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

Acronym: ASG-EI

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Dec 17, 2024
Registry last updated: Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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