Facial Asymmetry Malocclusion
Conditions
Interventions
This is a prospective, single-arm interventional clinical study with one arm, non-randomized allocation, and open-label design. The study will include 20 participants, all of whom will receive the sam
Sponsors
Universidade Santo Amaro
Universidade Santo Amaro
Eligibility
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Adults between 18 and 55 years old. Both sexes. Good general health. Class I or II (A/B) according to the Angle classification. Agree to and sign the terms of the Informed Consent Form (ICF). Absence of prior facial aesthetic interventions within the last 12 months
Exclusion criteria
Exclusion criteria: Allergy to hyaluronic acid. Allergy to anesthetics such as lidocaine. Marked facial asymmetries. Previous facial surgeries. Coagulation disorders. Autoimmune diseases. Metabolic diseases. Pregnant and lactating women. Active infections, skin lesions, or recent herpes in the treatment area. Presence of permanent materials (PMMA, silicone, and facial prostheses). Class III according to the Angle classification. Recent use of facial fillers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to observe improvement in self-reported facial aesthetic perception related to the facial profile after profileplasty with hyaluronic acid, verified through the application of the FACE-Q questionnaire, using the Satisfaction with Facial Appearance domain associated with the specific modules for evaluation of the nose, lips, and chin, in the pre-intervention period and 30 days after the procedure, an interval defined as corresponding to the period necessary for the resolution of transient effects, such as edema and inflammation, and for tissue accommodation of the filler, allowing a more reliable assessment of the stabilized aesthetic result; the variation in the scores of these domains will be evaluated, considering as clinically relevant improvement a minimum increase of 10 points in the transformed score (scale from 0 to 100) between the pre- and post-intervention time points | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective changes in the facial profile are expected to be identified after the intervention, verified through cephalometric, anthropometric, and digital analyses, using standardized photographic and radiographic documentation, Robert Murray Ricketts tracing, and measurements performed with the FIJI software, with evaluation of variations in linear and angular measurements of the facial profile, including lip projection (Ricketts’ E-line), nasolabial angle, mentolabial angle, facial convexity, and vertical and horizontal facial proportions, considering a minimum variation of 5% between pre- and post-intervention periods as a significant change | — |
Countries
BR
Contacts
Public ContactSumaya Bordalo
Universidade Santo Amaro
Outcome results
None listed