Effect of an AI Prediction Model of Facial Changes After Orthodontic Treatment of Patients With Bimaxillary Protrusion

NCT ID: NCT07066423

Last Updated: 2025-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-11-01

Brief Summary

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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

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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

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Bimaxillary Protrusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Ai prediction group

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.

Group Type EXPERIMENTAL

Ai prediction photo of the patients

Intervention Type OTHER

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 extraction

Intervention Type PROCEDURE

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.

Control group

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.

Group Type ACTIVE_COMPARATOR

Fixed orthodontic brackets with premolars extraction

Intervention Type PROCEDURE

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.

Interventions

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Ai prediction photo of the patients

Ai prediction photo generated by specially designed ai model to help patients see how they will look after orthodontic extraction and retraction

Intervention Type OTHER

Fixed orthodontic brackets with premolars extraction

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Adult cases age range from 16 to 30 years old
2. Skeletal Bimaxillary protrusion with SNA and SNB increased
3. Dental bimaxillary protrusion with U1- SN and IMP a increased angles
4. Class I canine and molar angle classification
5. Free from any systemic disease
6. free from any dental surgery

Exclusion Criteria

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Kholoud Mandour

PHD candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shaza Hammad, professor

Role: STUDY_DIRECTOR

Mansoura University

Marwa Shamaa, Professor

Role: STUDY_CHAIR

Mansoura University

Ahmed Kamel, Lecturer

Role: STUDY_CHAIR

Mansoura University

Locations

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Mansoura university

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Related Links

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https://link.springer.com/article/10.1631/jzus.B2300244#citeas

Development and accuracy of artificial intelligence-generated prediction of facial changes in orthodontic treatment: a scoping review

Other Identifiers

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PHD Candidate Kholoud Mandour

Identifier Type: -

Identifier Source: org_study_id

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