Quantitative Evaluation of Attention to Faces After Orthognathic Surgery With Eye-tracking

NCT06494709 | Recruiting

• 1 other identifier: PI2022_843_0146
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Dentofacial deformities refer to morphological anomalies of the jaws. Their development during growth determines the shape of the lower third of the face and the type of dental occlusion. A maxillo-mandibular dysmorphosis associates morphological modification of the face and anomaly of the occlusion. If these anomalies are most often hereditary, they also depend on acquired factors such as swallowing, breathing, sucking or phonation disorders. Angle's classification defines three classes of dental occlusion: class I, when the ratio between the maxillary and mandibular first molars is normal, class II when the upper molar is too far forward, and class III when it is too far back. Class II and III dysmorphoses can result in an alteration of the masticatory function, pain (TMJ, headaches) or sleep apnea. At the same time, they cause patients to experience a decrease in self-esteem, anxiety and social discomfort. Class II and II usually require orthodontic treatment and orthognathic surgery to correctly align the jaws. This surgery has a positive impact on the dental occlusion and the functions concerned, but also on the facial morphology, all of which often leads to an improvement in the patient's quality of life. Standardized photographs presenting control subjects (class I) and patients (class II and class III) before and after surgery will be included in an approximately 10 min video sequence. Naive participants will look at this sequence during which the faces of the controls and the patients - before and after surgery - will alternate, with the instruction being free visual exploration of the images. The total fixation durations in defined areas of interest (eyes, nose, mouth, chin) will be recorded with an eye tracking device and the results will be processed using a dedicated software.

Conditions

Dentofacial Deformities; Orthognathic Surgery; Social Perception; Eye Tracking

Keywords

Dentofacial Deformities; orthognathic surgery; social perception; eye tracking

Outcome Measures

Primary Outcomes (1)

• Total fixation duration in the "lower third of the face (mouth/chin)" area of interest

  Total fixation duration in the "lower third of the face (mouth/chin)" area of interest, measured in seconds with eye-tracking technique

  one day

Secondary Outcomes (5)

• Total fixation duration in the "eyes" area of interest

  one day

• Total fixation duration in the "nose"" area of interest

  one day

• Total fixation duration in the eyes", the "nose" and the "lower third of the face (mouth/chin)" areas of interest in patients before orthognathic surgery compared to control subjects.

  one day

• Total fixation duration in the eyes", the "nose" and the "lower third of the face (mouth/chin)" areas of interest in patients after orthognathic surgery compared to control subjects.

  one day

• Total fixation duration in the eyes", the "nose" and the "lower third of the face (mouth/chin)" areas of interest in class II patients before orthognathic surgery compared to class III patients.

  one day

Interventions

photographs OTHER

Standardized photographs presenting 10 control subjects (class I) and patients with dentofacial deformities (10 class II and 10 class III) before and after surgery - from the front and from the side - will be used to form an approximately 10 min video sequence using the Tobii Pro Lab® software (Tobii Pro AB, Danderyd, Sweden). The naive participants will look at the percept during which the faces of the controls and the patients will alternate, with the only instruction being free visual exploration of the percept. The fixation duration in the defined areas of interest (eyes, nose, mouth, chin) will be recorded with a Tobii® Pro X3-120 eye-tracking device and the results will be processed with the Tobii Pro Lab® software.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Naïve subject with regard to dentofacial deformities and their management
• Subject with no known facial pathology
• Subject having provided an informed consent
• Subject \> 18 years old

You may not qualify if:

• Subject familiar with dentofacial deformities and their management (e.g., health professionals in the relevant specialties)
• Subject with known facial pathology (dentofacial deformity or other)
• Subject under guardianship, curators or justice protection

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• Institut Faire Faces: collaborator

Study Sites (1)

Amiens University Hospital

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Dentofacial Deformities

Interventions

Moire Topography

Condition Hierarchy (Ancestors)

Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Stomatognathic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Photogrammetry; Photography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Interferometry; Investigative Techniques

Central Study Contacts

Stéphanie Dakpe, Pr

CONTACT

03 22 08 90 80; dakpe.stephanie@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: July 2, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)