Ignite Creation Date:
2024-07-17 @ 11:11 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494709
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-02
Brief Title:
Quantitative Evaluation of Attention to Faces After Orthognathic Surgery With Eye-tracking
Sponsor:
Centre Hospitalier Universitaire Amiens
Organization:
Centre Hospitalier Universitaire Amiens
Study Overview
Official Title:
Pilot Study of Quantitative Evaluation of Attention to Faces of Patients With Orthognathic Surgery Using Eye-tracking
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OCHIRO
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 Angles 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 patients 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None