MedDataX Logo

SURGICAL GUIDES EFFECTIVENESS

NCT ID: NCT06737289

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-11

Study Completion Date

2025-10-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrophic Maxilla

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Split Mouth Design
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
blind

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Guide Surgery Arm

Use of Surgical Guide

Group Type EXPERIMENTAL

Surgical Guide

Intervention Type PROCEDURE

Placing extralarge implats for rahabilitation atrophic maxilla

Control

Hand Free Implant Placement

Group Type PLACEBO_COMPARATOR

Surgical Guide

Intervention Type PROCEDURE

Placing extralarge implats for rahabilitation atrophic maxilla

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Surgical Guide

Placing extralarge implats for rahabilitation atrophic maxilla

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jesús Torres García Denche

Associate Profesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

JEsus Torres, PhD

Role: PRINCIPAL_INVESTIGATOR

UCM

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jesus

Madrid, , Spain

Site Status RECRUITING

UCM

Madrid, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jesus Torres, PhD

Role: CONTACT

Phone: 653050071

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jesus Torres, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C.I. 24/728-E

Identifier Type: -

Identifier Source: org_study_id