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

Sponsor
Al-Azhar University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05978856
Collaborator
(none)
30
1
19
1.6

Study Details

Study Description

Brief Summary

A clinical study to evaluate the accuracy of computer software in predicting soft tissue profile changes in patients undergoing fixed orthodontic treatment

Condition or Disease Intervention/Treatment Phase
  • Other: Accuracy of computer software in predicting soft tissue profile changes

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 Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
The Accuracy of Computer Software Prediction of Soft Tissue Profile for Patients Undergoing Fixed Orthodontic Treatment
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm 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

    Outcome Measures

    Primary Outcome Measures

    1. accuracy of computer software in predicting soft tissue profile changes [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dental medicine al-azhar university Assiut Assuit Egypt 12345

    Sponsors and Collaborators

    • Al-Azhar University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Salah Hasan Saleh Mohamed, General Physician at the Ministry of Health, Al-Azhar University
    ClinicalTrials.gov Identifier:
    NCT05978856
    Other Study ID Numbers:
    • VTO
    First Posted:
    Aug 7, 2023
    Last Update Posted:
    Aug 7, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Salah Hasan Saleh Mohamed, General Physician at the Ministry of Health, Al-Azhar University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 7, 2023