Splintless Virtual Surgical Plan with Mandible-first Technique: 3D Accuracy Analysis (MandiFirst)

March 26, 2025 updated by: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Splintless Virtual Surgical Plan with Mandible-first Technique in Orthognathic Surgery: Tridimensional Accuracy Analysis

Accuracy assessment through three-dimensional superposition of the post-operative volumetric CT and the digital therapeutic project files.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy, 20157
        • Recruiting
        • IRCCS Ospedale Galeazzi-Sant'Ambrogio
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with diagnosis of dentoskeletal disorders

Description

Inclusion Criteria:

  • Men and women
  • Age over 18 and under 60
  • Diagnosis of dento-skeletal dysmorphosis involving the middle third and lower part of the face
  • Patients with consent to surgery
  • Patients in good general health according to the evaluation of the PI and on the basis of the anamnesis and clinical examination

Exclusion Criteria:

  • History of previous maxillomandibular fracture
  • Treatment with anticoagulant drugs
  • Treatment with intravenous bisphosphonates
  • Treatment with anticonvulsants
  • Patient's inability to maintain home hygiene standards in accordance with the study requirements
  • History of drug and/or alcohol abuse
  • Chronic corticosteroid therapy
  • Radiotherapy, chemotherapy and/or immunosuppressive treatment or radiotherapy in the last 5 years
  • Psychosis
  • Pregnant or breastfeeding
  • Poor compliance
  • Endocrinological disorders in poor pharmacological control
  • Other uncontrolled systemic conditions that preclude performing surgical procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy evaluation
Time Frame: 1 month post-op

3D superposition of post-operative volumetric CT and the digital therapeutic project files.

The variables and parameters analysis will be performed after the data distribution analysis, using the D'Agostino Pearson omnibus normality test: normal distribution data will be expressed as mean and standard deviation; non-normal distribution data will be expressed as median and interquartile range.

The quantitative and qualitative variables will be expressed in terms of absolute frequencies and percentage value.

Image superposition accuracy will be defined by measuring distances between the different anatomical reference points, considering excellent accuracy for distances less than 2 mm. Correlation and multivariate analysis models will be developed to define the secondary outcomes.
1 month post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2024

Primary Completion (Actual)

September 30, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 18, 2024

First Submitted That Met QC Criteria

March 26, 2025

First Posted (Actual)

April 2, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 26, 2025

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mandible First

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Scientific Pubblication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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