Quantitative Evaluation of Attention to Faces After Orthognathic Surgery With Eye-tracking
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: photographs.
- Who it may be relevant to
- Registry conditions: Dentofacial Deformities, Orthognathic Surgery, Social Perception, Eye Tracking. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Study of Quantitative Evaluation of Attention to Faces of Patients With Orthognathic Surgery Using Eye-tracking
Overview
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.
Interventions
- Other photographs
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 explora
Primary outcome measures
- Total fixation duration in the "lower third of the face (mouth/chin)" area of interest [Time frame: one day]
Secondary outcome measures (5)
- Total fixation duration in the "eyes" area of interest [Time frame: one day]
- Total fixation duration in the "nose"" area of interest [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: one day]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Amiens University Hospital — Amiens
Identifiers
NCT: NCT06494709 · PI2022_843_0146