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

NCT05978856 | Unknown

• 1 other identifier: VTO
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Malocclusion

Keywords

VTO; orthodontic software; prediction

Outcome Measures

Primary Outcomes (1)

• 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 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

Study Arms (2)

A

real photoes (after treatment)

Other: Accuracy of computer software in predicting soft tissue profile changes

B

simulated photoes

Interventions

Accuracy of computer software in predicting soft tissue profile changes OTHER

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.

Also known as: visual treatment objective

A

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Dental medicine al-azhar university

Asyut, Assuit, 12345, Egypt

RECRUITING

Related Publications (12)

• Kolokitha OE, Chatzistavrou E. Factors influencing the accuracy of cephalometric prediction of soft tissue profile changes following orthognathic surgery. J Maxillofac Oral Surg. 2012 Mar;11(1):82-90. doi: 10.1007/s12663-011-0253-6. Epub 2011 Jul 7.

  PMID: 23450114 BACKGROUND

• Kolokitha OE. Validity of a manual soft tissue profile prediction method following mandibular setback osteotomy. Eur J Dent. 2007 Oct;1(4):202-11.

  PMID: 19212468 BACKGROUND

• Leonardi R, Annunziata A, Licciardello V, Barbato E. Soft tissue changes following the extraction of premolars in nongrowing patients with bimaxillary protrusion. A systematic review. Angle Orthod. 2010 Jan;80(1):211-6. doi: 10.2319/010709-16.1.

  PMID: 19852663 BACKGROUND

• Drobocky OB, Smith RJ. Changes in facial profile during orthodontic treatment with extraction of four first premolars. Am J Orthod Dentofacial Orthop. 1989 Mar;95(3):220-30. doi: 10.1016/0889-5406(89)90052-8.

  PMID: 2923102 BACKGROUND

• Al-Omiri MK, Abu Alhaija ES. Factors affecting patient satisfaction after orthodontic treatment. Angle Orthod. 2006 May;76(3):422-31. doi: 10.1043/0003-3219(2006)076[0422:FAPSAO]2.0.CO;2.

  PMID: 16637722 BACKGROUND

• Kolokitha OE, Topouzelis N. Cephalometric methods of prediction in orthognathic surgery. J Maxillofac Oral Surg. 2011 Sep;10(3):236-45. doi: 10.1007/s12663-011-0228-7. Epub 2011 May 17.

  PMID: 22942594 BACKGROUND

• Smith JD, Thomas PM, Proffit WR. A comparison of current prediction imaging programs. Am J Orthod Dentofacial Orthop. 2004 May;125(5):527-36. doi: 10.1016/S0889540604001210.

  PMID: 15127020 BACKGROUND

• Patterson Dental Supply. Imaging. In: Dolphin Imaging. 2012. Retrieved December 17th 2012, from http://www.dolphinimaging.com/imaging.html.

  BACKGROUND

• Gossett CB, Preston CB, Dunford R, Lampasso J. Prediction accuracy of computer-assisted surgical visual treatment objectives as compared with conventional visual treatment objectives. J Oral Maxillofac Surg. 2005 May;63(5):609-17. doi: 10.1016/j.joms.2005.01.004.

  PMID: 15883933 BACKGROUND

• Ioannidou-Marathiotou I, Papamanou DA, Papadopoulos MA. Orthodontics and esthetics of the face: from the "canons" of ancient times to contemporary pluralism. A critical review. Prog Orthod. 2008;9(2):20-33.

  PMID: 19350056 BACKGROUND

• Prabhakar R, Rajakumar P, Karthikeyan MK, Saravanan R, Vikram NR, Reddy A. A hard tissue cephalometric comparative study between hand tracing and computerized tracing. J Pharm Bioallied Sci. 2014 Jul;6(Suppl 1):S101-6. doi: 10.4103/0975-7406.137401.

  PMID: 25210347 BACKGROUND

• Nadjmi N, Tehranchi A, Azami N, Saedi B, Mollemans W. Comparison of soft-tissue profiles in Le Fort I osteotomy patients with Dolphin and Maxilim softwares. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):654-62. doi: 10.1016/j.ajodo.2013.06.019.

  PMID: 24182581 BACKGROUND

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

salah hasan, gp

CONTACT

01125237178; dr.salah.hassan.1995@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Physician at the Ministry of Health

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 7, 2023
• Study Start: August 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 7, 2023

Record last verified: 2023-07

Locations

EG (1)