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

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ClinicalTrials.gov Identifier: NCT05978856
Recruitment Status : Recruiting
First Posted : August 7, 2023
Last Update Posted : August 7, 2023
Sponsor:
Information provided by (Responsible Party):
Salah Hasan Saleh Mohamed, Al-Azhar University

Study Description
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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
Dental Malocclusion 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
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Study Type : Observational
Estimated 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
Estimated Study Start Date : August 1, 2023
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

Groups and Cohorts
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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 Name: visual treatment objective
B
simulated photoes


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05978856


Contacts
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Contact: salah hasan, gp 01125237178 dr.salah.hassan.1995@gmail.com

Locations
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Egypt
Dental medicine al-azhar university Recruiting
Assiut, Assuit, Egypt, 12345
Contact: abd-AlAziz A baioumy, professor    0020882181056    aadj@azhar.edu.eg   
Sponsors and Collaborators
Al-Azhar University
More Information
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Publications:
Patterson Dental Supply. Imaging. In: Dolphin Imaging. 2012. Retrieved December 17th 2012, from http://www.dolphinimaging.com/imaging.html.

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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: August 7, 2023    Key Record Dates
Last Update Posted: August 7, 2023
Last Verified: July 2023

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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, Al-Azhar University:
VTO
orthodontic software
prediction
Additional relevant MeSH terms:
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Malocclusion
Tooth Diseases
Stomatognathic Diseases