Dental Malocclusion Clinical Trial
Official title:
The Accuracy of Computer Software Prediction of Soft Tissue Profile for Patients Undergoing Fixed Orthodontic Treatment
NCT number | NCT05978856 |
Other study ID # | VTO |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2023 |
Est. completion date | March 1, 2025 |
A clinical study to evaluate the accuracy of computer software in predicting soft tissue profile changes in patients undergoing fixed orthodontic treatment
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Dental medicine al-azhar university | Assiut | Assuit |
Lead Sponsor | Collaborator |
---|---|
Al-Azhar University |
Egypt,
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
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 |
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