Bimaxillary ProtrusionAiNCT07066423
Effect of an AI Prediction Model of Facial Changes After Orthodontic Treatment of Patients With Bimaxillary Protrusion
A study testing Ai prediction photo of the patients and Fixed orthodontic brackets with premolars extraction in people with Bimaxillary Protrusion, run by Mansoura University at 1 site in Egypt.
Trial summary
After developing an Artificial Intelligence model to predict the facial changes of patients with bimaxillary protrusion following orthodontic extraction of premolars and tooth retraction, participants will view a prediction in the form of a picture generated by the AI model, and their motivation will be measured using… Read more about this study
- Who is it for?
- Ages 16 to 30 years
- Conditions the study is for
- Bimaxillary Protrusion
- What is being tested?
- Ai prediction photo of the patients and Fixed orthodontic brackets with premolars extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adult cases age range from 16 to 30 years old
- Skeletal Bimaxillary protrusion with SNA and SNB increased
- Dental bimaxillary protrusion with U1- SN and IMP a increased angles
- Class I canine and molar angle classification
- Free from any systemic disease
- free from any dental surgery
Who cannot join
- Clefts of the lip or palate and craniofacial syndromes; orthognathic patients will not be included because they do not represent the general adult orthodontic population
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact Of Artificial Intelligence-Based Prediction of Facial Changes in Bimaxillary Protrusion Cases on Patient Motivation and Satisfaction
After developing an Artificial Intelligence model to predict the facial changes of patients with bimaxillary protrusion following orthodontic extraction of premolars and tooth retraction, participants will view a prediction in the form of a picture generated by the AI model, and their motivation will be measured using a questionnaire. Their satisfaction will be evaluated using another questionnaire after they complete their treatment. A comparison will then be made between the actual results and the AI-predicted results.
Read the detailed description
Subjects will be selected according to the inclusion criteria previously listed, and they will present the needed records for participating in the study. After taking initial photos of the patients before treatment, these photos will be uploaded to the AI model to generate the prediction photo, the selected subjects for the prediction group will view their AI-predicted photo, and their motivation will be evaluated by a questionnaire.
The control group will not view a prediction photo; they will answer the motivation questionnaire only.
- Conditions
- Bimaxillary Protrusion
- Being tested
- Ai prediction photo of the patients, Fixed orthodontic brackets with premolars extraction
- Keywords
- Bimaxillary protrusion, prediction, Artificial intelligence, retraction, facial
- Medical subject headings
- Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ai prediction photo of the patientsOther
Ai prediction photo generated by specially designed ai model to help patients see how they will look after orthodontic extraction and retraction
Fixed orthodontic brackets with premolars extractionProcedure or surgery
Subjects will undergo orthodontic fixed brackets treatment, four premolar extractions from the mandibular and maxillary arches, followed by anterior segment retraction. This treatment will achieve dental alignment, profile, and facial enhancement.
| Study group | Role | What they receive |
|---|---|---|
| Ai prediction group | Experimental | The participant group that will be exposed to prediction photos and measure their motivation for the four 1st premolars extraction decision, also undergoes the orthodontic treatment. Receives: Other: Ai prediction photo of the patients; Procedure: Fixed orthodontic brackets with premolars extraction |
| Control group | Active comparator | Subjects in this group will receive orthodontic treatment and answer a questionnaire about their motivation and satisfaction with the treatment, but they will not be exposed to AI prediction photos. Receives: Procedure: Fixed orthodontic brackets with premolars extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants motivation for treatment
The motivation questionnaire will be performed to test if the prediction picture will affect their motivation to continue the treatment and proceed with the extraction decision. The questions will be in the multiple-choice format.
Open-ended comments were allowed at the end of each question to collect data concerning reasons, barriers, and encouraging factors that the authors may not have considered.
The questionnaire Arabic version will be used as it was validated by authors Felemban et al. in 2022. Based on the English version used by Chambers et al. 2019 and Laothong et al. in 2017, a modification will be added to the questionnaire regarding a question about how the prediction picture affected their motivation.
After the treatment of each case, a 5-point Likert scale will be used to measure their satisfaction with the treatment and whether the net result matches the AI prediction, with 1 for not satisfied at all and 5 for satisfied.
Measured: from three weeks to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Nov 2023
- Primary completion15 Sep 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bimaxillary ProtrusionStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kholoud Mandour, Mansoura University
- Investigators
- Shaza Hammad, professor, Study director, Mansoura UniversityMarwa Shamaa, Professor, Study chair, Mansoura UniversityAhmed Kamel, Lecturer, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066423
- Sponsor's protocol ID
- PHD Candidate Kholoud Mandour
- Acronym
- Ai
- Status last verified
- Jul 2025
- First submitted
- 2 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Of Artificial Intelligence-Based Prediction of Facial Changes in Bimaxillary Protrusion Cases on Patient Motivation and Satisfaction
- ClinicalTrials.gov ID
- NCT07066423
- Acronym / sponsor ID
- Ai / PHD Candidate Kholoud Mandour
- Conditions
- Bimaxillary Protrusion
- Keywords
- Bimaxillary protrusion, prediction, Artificial intelligence, retraction, facial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 15 Jul 2025 (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.
After developing an Artificial Intelligence model to predict the facial changes of patients with bimaxillary protrusion following orthodontic extraction of premolars and tooth retraction, participants will view a prediction in the form of a picture generated by the AI model, and their motivation will be measured using a questionnaire. Their satisfaction will be evaluated using another questionnaire after they complete their treatment. A comparison will then be made between the actual results and the AI-predicted results.
Detailed description
Subjects will be selected according to the inclusion criteria previously listed, and they will present the needed records for participating in the study. After taking initial photos of the patients before treatment, these photos will be uploaded to the AI model to generate the prediction photo, the selected subjects for the prediction group will view their AI-predicted photo, and their motivation will be evaluated by a questionnaire.
The control group will not view a prediction photo; they will answer the motivation questionnaire only.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ai prediction group | Experimental | Other: Ai prediction photo of the patients, Procedure: Fixed orthodontic brackets with premolars extractionThe participant group that will be exposed to prediction photos and measure their motivation for the four 1st premolars extraction decision, also undergoes the orthodontic treatment. |
| Control group | Active comparator | Procedure: Fixed orthodontic brackets with premolars extractionSubjects in this group will receive orthodontic treatment and answer a questionnaire about their motivation and satisfaction with the treatment, but they will not be exposed to AI prediction photos. |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Adult cases age range from 16 to 30 years old
- Skeletal Bimaxillary protrusion with SNA and SNB increased
- Dental bimaxillary protrusion with U1- SN and IMP a increased angles
- Class I canine and molar angle classification
- Free from any systemic disease
Key exclusion criteria (1 listed)
- Clefts of the lip or palate and craniofacial syndromes; orthognathic patients will not be included because they do not represent the general adult orthodontic population
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 |
|---|---|---|
| Ai prediction photo of the patientsAi prediction photo generated by specially designed ai model to help patients see how they will look after orthodontic extraction and retraction | Other | Ai prediction group |
| Fixed orthodontic brackets with premolars extractionSubjects will undergo orthodontic fixed brackets treatment, four premolar extractions from the mandibular and maxillary arches, followed by anterior segment retraction. This treatment will achieve dental alignment, profile, and facial enhancement. | Procedure or surgery | Ai prediction group, Control group |
Primary outcome
Participants motivation for treatment
Time frame: from three weeks to six months
The motivation questionnaire will be performed to test if the prediction picture will affect their motivation to continue the treatment and proceed with the extraction decision. The questions will be in the multiple-choice format. Open-ended comments were allowed at the end of each question to collect data concerning reasons, barriers, and encouraging factors that the authors may not have considered. The questionnaire Arabic version will be used as it was validated by authors Felemban et al. in 2022. Based on the English version used by Chambers et al. 2019 and Laothong et al. in 2017, a modification will be added to the questionnaire regarding a question about how the prediction picture affected their motivation. After the treatment of each case, a 5-point Likert scale will be used to measure their satisfaction with the treatment and whether the net result matches the AI prediction, with 1 for not satisfied at all and 5 for satisfied.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Development and accuracy of artificial intelligence-generated prediction of facial changes in orthodontic treatment: a scoping reviewLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Bimaxillary Protrusion
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Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Not yet recruiting
Survival, Success, Stability, and Patient Comfort of TADs Placed by Steady Oblique-Angled Versus Two-Step Angulation Insertion Techniques
Bimaxillary Proclination, Bimaxillary Protrusion
Recruiting
LLLLT vs Piezocision in Accelerating Orthodontic Canine Retraction
Malocclusion, Angle Class II, Division 1, Bimaxillary Protrusion
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.
Shaza Hammad, professor study director
Mansoura University
Marwa Shamaa, Professor study chair
Mansoura University
Ahmed Kamel, Lecturer study chair
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ai prediction photo of the patients and Fixed orthodontic brackets with premolars extraction in people with Bimaxillary Protrusion, run by Mansoura 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?
The sponsor lists 6 inclusion and 1 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants motivation for treatment (time frame: from three weeks to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2025.