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

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

Tracking Information

• First Submitted Date: July 17, 2023
• First Posted Date: August 7, 2023
• Last Update Posted Date: August 7, 2023
• Estimated Study Start Date: August 1, 2023
• Estimated Primary Completion Date: January 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 30, 2023)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Accuracy of Computer Software Prediction of Soft Tissue Profile for Patients Undergoing Fixed Orthodontic Treatment
• Official Title: The Accuracy of Computer Software Prediction of Soft Tissue Profile for Patients Undergoing Fixed Orthodontic Treatment
• Brief Summary: A clinical study to evaluate the accuracy of computer software in predicting soft tissue profile changes in patients undergoing fixed orthodontic 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
• Study Design: Observational Model: Other; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Dental Malocclusion

Intervention

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

Study Groups/Cohorts

• A
  real photoes (after treatment)
  Intervention: Other: Accuracy of computer software in predicting soft tissue profile changes
• B
  simulated photoes

Publications *

• 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.
• Kolokitha OE. Validity of a manual soft tissue profile prediction method following mandibular setback osteotomy. Eur J Dent. 2007 Oct;1(4):202-11.
• 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.
• 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.
• 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.
• 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.
• 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.
• Patterson Dental Supply. Imaging. In: Dolphin Imaging. 2012. Retrieved December 17th 2012, from http://www.dolphinimaging.com/imaging.html.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 30, 2023): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 1, 2025
• Estimated Primary Completion Date: January 1, 2025 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years to 35 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Contacts

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

• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT05978856
• Other Study ID Numbers: VTO
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Salah Hasan Saleh Mohamed, Al-Azhar University
• Original Responsible Party: Same as current
• Current Study Sponsor: Al-Azhar University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Al-Azhar University
• Verification Date: July 2023