Malocclusion, Angle Class II Retrognathia
Conditions
Interventions
A total of 40 patients will be randomized in a 1 to 1 ratio into two groups, with the intervention group receiving botulinum toxin associated with hyaluronic acid filler and the control group receivin
Sponsors
Centro Universitário Ingá
Centro Universitário Ingá
Eligibility
Age
No minimum to 50 Years
Inclusion criteria
Inclusion criteria: Individuals of both sexes aged between 18 and 50 years, presenting moderate to severe chin retrusion, defined as grades 2 or 3 according to the Chin Retrusion Scale of Allergan, confirmed by standardized clinical assessment
Exclusion criteria
Exclusion criteria: Individuals with a history of prior chin correction using non permanent fillers or permanent implants, as well as individuals presenting any contraindication to injections, will not be eligible to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess chin projection, verified by measuring the distance between the true vertical line and the menton in centimeters through standardized photographic analysis performed at baseline, post treatment, and at the 30 day follow up, with reduction of negative values being observed or expected, indicating improvement in anterior chin projection; assess jawline definition, verified by measuring the gonion to menton distance in centimeters through standardized photographic analysis at the same evaluation time points, with an increase in this distance being observed or expected, reflecting improvement in mandibular contour and definition | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess overall clinical improvement of chin retrusion, verified by the proportion of participants achieving at least a one grade improvement on a validated chin retrusion scale, with an increased percentage of responders being observed or expected after treatment; assess global aesthetic improvement, verified through a global aesthetic improvement scale applied to patients, with scores indicating improvement such as improved or much improved being observed or expected; assess patient satisfaction with facial appearance, verified through validated questionnaires of quality of life and aesthetic perception applied to the chin, jawline, and overall face, with increased mean satisfaction scores compared to baseline being observed or expected; assess psychosocial impact related to appearance, verified through standardized instruments measuring psychological well being and social function, with improvements in scores related to self confidence and social interaction being observed or expected; assess procedure related pain, verified using a visual analog scale from 0 to 10 during and after application, with low to moderate mean values being observed or expected; assess treatment safety and tolerability, verified through the recording of immediate and delayed adverse events, with a low incidence of complications and absence of serious adverse events being observed or expected | — |
Countries
BR
Contacts
Public ContactRenato Machado
Centro Universitário Ingá
Outcome results
None listed