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

Dental Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05978856
• Other study ID #: VTO
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: July 2023
• Source: Al-Azhar University
• Contact: salah hasan, gp
• Phone: 01125237178
• Email: dr.salah.hassan.1995[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Malocclusion
• 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.

Locations

Country	Name	City	State
Egypt	Dental medicine al-azhar university	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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