The Accuracy of Computer Software Prediction of Soft Tissue Profile for Patients Undergoing Fixed Orthodontic Treatment

July 30, 2023 updated by: Salah Hasan Saleh Mohamed, Al-Azhar University
A clinical study to evaluate the accuracy of computer software in predicting soft tissue profile changes in patients undergoing fixed orthodontic treatment

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The computer software programs exhibit certain soft tissue simulation . The purpose of the study to assess the accuracy of computer software in predicting profile changes in patients undergoing fixed orthodontic treatment

Study Type

Observational

Enrollment (Estimated)

30

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

  • Egypt
    • Assuit
      • Assiut, Assuit, Egypt, 12345
        • Recruiting
        • Dental Medicine Al-Azhar University
        • Contact:
          • abd-AlAziz A baioumy, professor
          • Phone Number: 0020882181056
          • Email: aadj@azhar.edu.eg

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

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study will be performed on patients treate in the orthodontics department, faculty of dentistry, alazhar university,assuit branch.

Description

The inclusion criteria included:

  • Patient undergo fixed orthodontic treatment with the edgewise technique.
  • Skeletal class I.
  • Dental class I or II or III.
  • Final class I occlusion without spacing or crowding, with normal overjet and overbite (2-4 mm)
  • Availability of full diagnostic and therapeutic records before to and following orthodontic treatment, including medical and dental history, dental casts, panoramic and cephalometric x-rays, and photographic photographs.

The exclusion criteria included:

  • Missing tooth or significant Bolton discrepancies (more than 3 mm).
  • Craniofacial syndromes or skeletal abnormalities.
  • Failed orthodontic treatment in the past.
  • Cosmetic or reconstructive facial surgery during orthodontic treatment, or up to a year beforehand.
  • Using drugs that could reduce the volume of soft tissues.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
real photoes (after treatment)
Other: Accuracy of computer software in predicting soft tissue profile changes

Separate analyses will be performed on the initial and final cephalograms.

  • All of the cephalometric analyses will be done via computer software,the linear and angular measurements will be done via the software.
  • Through the use of software, the initial cephalogram and the initial photograph will be linked.
  • Then, the final values of some angles will be tracted from the post-treatment cephalogram.
  • These values will be inserted in the "treatment simulation"section of the software.
  • A post-treatment projected image of the patient will be simulated by the software.
  • Then the actual post-treatment photograph will be placed on the simulated image in transparent form.
  • From the pupil , real horizontal and vertical reference lines will be drawn.
  • Then certain measurements will be taken from referance lines to fixed points on the soft tissue to determine the discrepancies between the real and simulated images.
Other Names:
  • visual treatment objective
B
simulated photoes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
accuracy of computer software in predicting soft tissue profile changes
Time Frame: through study completion, an average of 1 year
  • Separate analyses will be performed on the initial and final cephalograms.
  • All of the cephalometric analyses will be done via computer software; the linear and angular measurements will be done via the software.
  • Through the use of software, the initial cephalogram and the initial photograph will be linked.
  • Then, the final values of some angles will be extracted from the post-treatment cephalogram.
  • These values will be inserted in the "treatment simulation" section of the software.
  • A post-treatment projected image of the patient will be simulated by the software.
  • Then the actual post-treatment photograph will be placed on the simulated image in transparent form.
  • From the pupil , real horizontal and vertical reference lines will be drawn.
  • Then certain measurements will be taken from reference lines to fixed points on the soft tissue to determine the discrepancies between the real and simulated images.
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Al-Azhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

August 1, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

July 17, 2023

First Submitted That Met QC Criteria

July 30, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

July 30, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VTO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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