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NCT Number: NCT06494709

Quantitative Evaluation of Attention to Faces After Orthognathic Surgery With 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amiens University Hospital

Amiens, Picardie, 80054, France

Location status: Recruiting

Location contact

Agnès PAASCHE, MD

SUB_INVESTIGATOR

Alban DESTREZ, MD

SUB_INVESTIGATOR

Emilien COLIN, Dr

SUB_INVESTIGATOR

Federica CILIA, Dr

SUB_INVESTIGATOR

Julien BOUQUET, MD

SUB_INVESTIGATOR

Luc VANDROMME, Pr

SUB_INVESTIGATOR

Stéphanie DAKPE, MD

CONTACT

[email protected]

0033 3 22 66 83 25

Sylvie TESTELIN, Pr

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: one day

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

Secondary outcomes

  1. Total fixation duration in the "eyes" area of interest

    Time frame: one day

    Total fixation duration in the "eyes" area of interest, measured in seconds with eye-tracking technique

  2. Total fixation duration in the "nose"" area of interest

    Time frame: one day

    Total fixation duration in the "nose" area of interest, measured in seconds with eye-tracking technique

  3. 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 before orthognathic surgery compared to control subjects.

    measured in seconds with eye-tracking technique

  4. 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 patients after orthognathic surgery compared to control subjects.

    measured in seconds with eye-tracking technique

  5. 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Stéphanie Dakpe, Pr

CONTACT

[email protected]

03 22 08 90 80

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Institut Faire Faces

Registry information

Official study title

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

Acronym: OCHIRO

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2024
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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