Dental MalocclusionNCT05978856
The Accuracy of Computer Software Prediction of Soft Tissue Profile for Patients Undergoing Fixed Orthodontic Treatment
An observational study of Dental Malocclusion, run by Al-Azhar University at 1 site in Egypt.
Trial summary
A clinical study to evaluate the accuracy of computer software in predicting soft tissue profile changes in patients undergoing fixed orthodontic treatment Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Malocclusion
- What is being tested?
- Accuracy of computer software in predicting soft tissue profile changes
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study will be performed on patients treate in the orthodontics department, faculty of dentistry, alazhar university,assuit branch.
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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Dental medicine al-azhar university
Asyut, Assuit, 12345
abd-AlAziz A baioumy, professor, 0020882181056, aadj@azhar.edu.eg
About this study
A clinical study to evaluate the accuracy of computer software in predicting soft tissue profile changes in patients undergoing fixed orthodontic treatment
Read the 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
- Conditions
- Dental Malocclusion
- Being tested
- Accuracy of computer software in predicting soft tissue profile changes
- Keywords
- VTO, orthodontic software, prediction
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accuracy of computer software in predicting soft tissue profile changesOther
Also called visual treatment objective
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.
| Study group | Role | What they receive |
|---|---|---|
| A | real photoes (after treatment) Receives: Other: Accuracy of computer software in predicting soft tissue profile changes | |
| B | simulated photoes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Dental MalocclusionStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salah Hasan Saleh Mohamed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978856
- Sponsor's protocol ID
- VTO
- Status last verified
- Jul 2023
- First submitted
- 17 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 23450114Kolokitha OE. Validity of a manual soft tissue profile prediction method following mandibular setback osteotomy. Eur J Dent. 2007 Oct;1(4):202-11.
PubMed 19212468Leonardi 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.
PubMed 19852663Drobocky 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.
PubMed 2923102Al-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.
PubMed 16637722Kolokitha 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.
PubMed 22942594Smith 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.
PubMed 15127020Patterson 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.
PubMed 15883933Ioannidou-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.
PubMed 19350056Prabhakar 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.
PubMed 25210347Nadjmi 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.
PubMed 24182581
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Computer Software Prediction of Soft Tissue Profile for Patients Undergoing Fixed Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT05978856
- Acronym / sponsor ID
- VTO
- Conditions
- Dental Malocclusion
- Keywords
- VTO, orthodontic software, prediction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: Accuracy of computer software in predicting soft tissue profile changesreal photoes (after treatment) |
| B | – | –simulated photoes |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study will be performed on patients treate in the orthodontics department, faculty of dentistry, alazhar university,assuit branch.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accuracy of computer software in predicting soft tissue profile changesAlso: visual treatment objectiveSeparate 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 | A |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Background: PubMed 23450114Kolokitha 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.
- Background: PubMed 19212468Kolokitha OE. Validity of a manual soft tissue profile prediction method following mandibular setback osteotomy. Eur J Dent. 2007 Oct;1(4):202-11.
- Background: PubMed 19852663Leonardi 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.
- Background: PubMed 2923102Drobocky 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.
- Background: PubMed 16637722Al-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.
- Background: PubMed 22942594Kolokitha 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.
- Background: PubMed 15127020Smith 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.
- BackgroundPatterson Dental Supply. Imaging. In: Dolphin Imaging. 2012. Retrieved December 17th 2012, from http://www.dolphinimaging.com/imaging.html.
- Background: PubMed 15883933Gossett 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.
- Background: PubMed 19350056Ioannidou-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.
- Background: PubMed 25210347Prabhakar 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.
- Background: PubMed 24182581Nadjmi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Malocclusion, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact salah hasan, gp (01125237178, dr.salah.hassan.1995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of computer software in predicting soft tissue profile changes (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05978856, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.