SURGICAL GUIDES EFFECTIVENESS

NCT06737289 | Recruiting

• 1 other identifier: C.I. 24/728-E
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Atrophic Maxilla

Outcome Measures

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.

  12 months

Study Arms (2)

Guide Surgery Arm

EXPERIMENTAL

Use of Surgical Guide

Procedure: Surgical Guide

Control

PLACEBO COMPARATOR

Hand Free Implant Placement

Procedure: Surgical Guide

Interventions

Surgical Guide PROCEDURE

Placing extralarge implats for rahabilitation atrophic maxilla

Control; Guide Surgery Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (2)

Jesus

Madrid, 28040, Spain

RECRUITING

UCM

Madrid, 28040, Spain

RECRUITING

MeSH Terms

Conditions

Atrophic Maxilla

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Maxillary Diseases; Jaw Diseases; Stomatognathic Diseases

Study Officials

• JEsus Torres, PhD

  UCM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesus Torres, PhD

CONTACT

653050071; jesus.torres@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Profesor

Model Details: Split Mouth Design

Study Record Dates

• First Submitted: November 30, 2024
• First Posted: December 17, 2024
• Study Start: December 11, 2024
• Primary Completion: June 12, 2025
• Study Completion: October 12, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-11

Locations

ES (2)