NCT05978856|Unknown
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Sponsor study identifier
observational
30
1 country
1
Study Start
August 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
A clinical study to evaluate the accuracy of computer software in predicting soft tissue profile changes in patients undergoing fixed orthodontic treatment
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 17, 2023
Actual (reported)August 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 7, 2023
Actual (reported)January 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
real photoes (after treatment)
simulated photoes
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The study will be performed on patients treate in the orthodontics department, faculty of dentistry, alazhar university,assuit branch.
Dental medicine al-azhar university
Asyut, Assuit, 12345, Egypt
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.
First Submitted
July 17, 2023
First Posted
August 7, 2023
Study Start
August 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 1, 2025
Pain and Activity Levels After Orthodontic Separators
Contact the study team to confirm eligibility.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 7, 2023
Record last verified: 2023-07
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