Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT05978856
Status:
UNKNOWN
Last Update Posted:
2023-08-07
First Post:
2023-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Accuracy of Computer Software Prediction of Soft Tissue Profile for Patients Undergoing Fixed Orthodontic Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008310', 'term': 'Malocclusion'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-30', 'studyFirstSubmitDate': '2023-07-17', 'studyFirstSubmitQcDate': '2023-07-30', 'lastUpdatePostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'accuracy of computer software in predicting soft tissue profile changes', 'timeFrame': 'through study completion, an average of 1 year', 'description': '* Separate analyses will be performed on the initial and final cephalograms.\n* All of the cephalometric analyses will be done via computer software; the linear and angular measurements will be done via the software.\n* Through the use of software, the initial cephalogram and the initial photograph will be linked.\n* Then, the final values of some angles will be extracted from the post-treatment cephalogram.\n* These values will be inserted in the "treatment simulation" section of the software.\n* A post-treatment projected image of the patient will be simulated by the software.\n* Then the actual post-treatment photograph will be placed on the simulated image in transparent form.\n* From the pupil , real horizontal and vertical reference lines will be drawn.\n* 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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VTO', 'orthodontic software', 'prediction'], 'conditions': ['Dental Malocclusion']}, 'referencesModule': {'references': [{'pmid': '23450114', 'type': 'BACKGROUND', '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.'}, {'pmid': '19212468', 'type': 'BACKGROUND', '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.'}, {'pmid': '19852663', 'type': 'BACKGROUND', '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.'}, {'pmid': '2923102', 'type': 'BACKGROUND', '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.'}, {'pmid': '16637722', 'type': 'BACKGROUND', 'citation': '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': '22942594', 'type': 'BACKGROUND', '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.'}, {'pmid': '15127020', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', 'citation': 'Patterson Dental Supply. Imaging. In: Dolphin Imaging. 2012. Retrieved December 17th 2012, from http://www.dolphinimaging.com/imaging.html.'}, {'pmid': '15883933', 'type': 'BACKGROUND', '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.'}, {'pmid': '19350056', 'type': 'BACKGROUND', '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.'}, {'pmid': '25210347', 'type': 'BACKGROUND', 'citation': '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': '24182581', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'A clinical study to evaluate the accuracy of computer software in predicting soft tissue profile changes in patients undergoing fixed orthodontic treatment', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be performed on patients treate in the orthodontics department, faculty of dentistry, alazhar university,assuit branch.', 'healthyVolunteers': True, 'eligibilityCriteria': 'The inclusion criteria included:\n\n* Patient undergo fixed orthodontic treatment with the edgewise technique.\n* Skeletal class I.\n* Dental class I or II or III.\n* Final class I occlusion without spacing or crowding, with normal overjet and overbite (2-4 mm)\n* 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.\n\nThe exclusion criteria included:\n\n* Missing tooth or significant Bolton discrepancies (more than 3 mm).\n* Craniofacial syndromes or skeletal abnormalities.\n* Failed orthodontic treatment in the past.\n* Cosmetic or reconstructive facial surgery during orthodontic treatment, or up to a year beforehand.\n* Using drugs that could reduce the volume of soft tissues.'}, 'identificationModule': {'nctId': 'NCT05978856', 'briefTitle': 'The Accuracy of Computer Software Prediction of Soft Tissue Profile for Patients Undergoing Fixed Orthodontic Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'The Accuracy of Computer Software Prediction of Soft Tissue Profile for Patients Undergoing Fixed Orthodontic Treatment', 'orgStudyIdInfo': {'id': 'VTO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'real photoes (after treatment)', 'interventionNames': ['Other: Accuracy of computer software in predicting soft tissue profile changes']}, {'label': 'B', 'description': 'simulated photoes'}], 'interventions': [{'name': 'Accuracy of computer software in predicting soft tissue profile changes', 'type': 'OTHER', 'otherNames': ['visual treatment objective'], 'description': 'Separate analyses will be performed on the initial and final cephalograms.\n\n* All of the cephalometric analyses will be done via computer software,the linear and angular measurements will be done via the software.\n* Through the use of software, the initial cephalogram and the initial photograph will be linked.\n* Then, the final values of some angles will be tracted from the post-treatment cephalogram.\n* These values will be inserted in the "treatment simulation"section of the software.\n* A post-treatment projected image of the patient will be simulated by the software.\n* Then the actual post-treatment photograph will be placed on the simulated image in transparent form.\n* From the pupil , real horizontal and vertical reference lines will be drawn.\n* 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.', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12345', 'city': 'Asyut', 'state': 'Assuit', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'abd-AlAziz A baioumy, professor', 'role': 'CONTACT', 'email': 'aadj@azhar.edu.eg', 'phone': '0020882181056'}], 'facility': 'Dental medicine al-azhar university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'salah hasan, gp', 'role': 'CONTACT', 'email': 'dr.salah.hassan.1995@gmail.com', 'phone': '01125237178'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'General Physician at the Ministry of Health', 'investigatorFullName': 'Salah Hasan Saleh Mohamed', 'investigatorAffiliation': 'Al-Azhar University'}}}}