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

Pilot Study of Quantitative Evaluation of Attention to Faces of Patients With Orthognathic Surgery Using Eye-tracking

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.

Study Overview

• Status: Recruiting
• Conditions: Orthognathic Surgery; Social Perception; Dentofacial Deformities; Eye Tracking
• Intervention / Treatment: Other: photographs

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stéphanie Dakpe, Pr; Phone Number: 03 22 08 90 80; Email: dakpe.stephanie@chu-amiens.fr

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • Recruiting
      • Amiens University Hospital
      • Sub-Investigator: Emilien Colin, Dr
      • Sub-Investigator: Luc VANDROMME, Pr
      • Sub-Investigator: Sylvie Testelin, Pr
      • Sub-Investigator: Agnès PAASCHE, MD
      • Sub-Investigator: Julien BOUQUET, MD
      • Sub-Investigator: Alban DESTREZ, MD
      • Sub-Investigator: Federica CILIA, Dr
      • Contact: Stéphanie DAKPE, MD; Phone Number: 0033 3 22 66 83 25; Email: dakpe.stephanie@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total fixation duration in the "eyes" area of interest	Total fixation duration in the "eyes" area of interest, measured in seconds with eye-tracking technique	one day
Total fixation duration in the "nose"" area of interest	Total fixation duration in the "nose" area of interest, measured in seconds with eye-tracking technique	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.	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. measured in seconds with eye-tracking technique	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.	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. measured in seconds with eye-tracking technique	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.	Total fixation duration in the eyes", the "nose" and the "lower third of the face (mouth/chin)" areas of interest in in class II patients before orthognathic surgery compared to class III patients. measured in seconds with eye-tracking technique	one day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: Institut Faire Faces

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: July 2, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: orthognathic surgery; eye tracking; social perception; Dentofacial Deformities
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Dentofacial Deformities
• Other Study ID Numbers: PI2022_843_0146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No