Gingival smile
Conditions
Interventions
Group A: 21 subjects with more than 4 mm of gingival exposure measured from the central incisor tooth were randomly allocated to receive 3 different doses of botulinum toxin:
7 subjects - single dose
Drug
Procedure/surgery
Sponsors
Centro Brasileiro de Estudos em Dermatologia
Centro Brasileiro de Estudos em Dermatologia
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Individuals aged between 18 and 70 years; Superior anterior gingival exposure: more than 4 mm, for subjects included in group A and 2 to 4 mm, for subjects included in group B; Presence of at least one indication for cosmetic treatment with botulinum toxin in the upper face; Medical history and physical examination that, in the opinion of the investigator, does not interfere with the progress of the study; Women of childbearing potential should have a negative urinary pregnancy test at visit 1. These subjects should use a highly effective contraception method during the study: combined oral contraceptives [estrogen and progesterone] or implanted contraceptives (with a stable dose for at least 1 month prior to study entry), bilateral tubal ligation, hormonal intrauterine device (inserted at least 1 month prior to study entry), strict abstinence (at least 1 month prior to entry into the study and agree to continue for the duration of the study), or vasectomized partner (at least 3 months prior to study entry) or use of condom; Women presenting for childbearing potential (e.g. before menstruation, post menopause (absence of menstrual bleeding for 1 year before entry into the study), hysterectomy, or bilateral ovariectomy, less than one year postmenopausal); Willingness to comply with protocol requirements and study duration. Understanding and signing the Informed Consent Term (ICF) at baseline, before any study procedure is performed.
Exclusion criteria
Exclusion criteria: Pregnant and/or breastfeeding women, or women who wish to become pregnant during the study period; Any surgical intervention that has affected the area evaluated in this study; Any cosmetic procedures, including fillers, or scars that may interfere with the results of the study; Previous treatment with botulinum toxin for gingival smile less than 6 months ago, or for other indications on the face less than 12 months ago; Evident facial asymmetry; Active inflammation or infections in the treated areas; Neoplastic, muscle or neurological diseases (e.g. Myasthenia Gravis, Lambert-Eaton Myasthenic Syndrome and motor neuron disease); Serious psychiatric disorders; Any other disease or chronic or serious decompensated medical condition that, in the opinion of the investigator, may interfere with the assessments or participation in the study or put subject at significant risk; History of sensitivity to the formula components; Current use of aminoglycoside antibiotics or penicillamines, quinines or calcium channel blockers or use at any time during the study; Coagulation disorders or use of anticoagulants; Vulnerable subjects (such as those deprived of their liberty) as defined in Section 1.61 of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) for Good Clinical Practice (GCP); Subjects with history of non-adherence to medications or showing difficulties to adhere to the study protocol; Current participation in another drug or device clinical study OR participation within 30 days prior to Day 1 OR in a period of exclusion from a previous clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Gingival exposure reduction (in mm) in subjects after treatment with botulinum toxin type A.;Observed outcome 1: Dose of 2.5U: mean reduction of 2.1±1.3 mm in gingival exposure 4 weeks after treatment and 1.2±0.9 mm 12 weeks after treatment. Dose of 5U: mean reduction of 3.5±1.4 mm in gingival exposure 4 weeks after treatment and 2.4±1.4 mm 12 weeks after treatment. Dose of 7.5U: mean reduction of 2.9±0.9 mm in gingival exposure 4 weeks after treatment and 1.9±1.0 mm 12 weeks after treatment. ;Expected outcome 2: Percentage of subjects with grades from 4 to 7 on the Jaeschke scale (evaluation by the independent panel) after treatment.;V3 55.9% of subjects who received the dose of 2.5U of abobotulinum toxin (Dysport®, Ipsen) reached grades 4 to 7 on the Jaeschke scale. 85.3% of subjects who received the dose of 5U of abobotulinum toxin (Dysport®, Ipsen) reached grades 4 to 7 on the Jaeschke scale. 85.7% of subjects who received the dose of 5U of abobotulinum toxin (Dysport®, Ipsen) reached grades 4 to 7 on the Jaeschke scale. V4 41.7% of subjects who received the dose of 2.5U of abobotulinum toxin (Dysport®, Ipsen) reached grades 4 to 7 on the Jaeschke scale. 76.5% of subjects who received the dose of 5U of abobotulinum toxin (Dysport®, Ipsen) reached grades 4 to 7 on the Jaeschke scale. 42.9% of subjects who received the dose of 5U of abobotulinum toxin (Dysport®, Ipsen) reached grades 4 to 7 on the Jaeschke scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Percentage of subjects satisfied with the treatment.;Observed outcome 1: Twelve weeks after treatment, more than 80% of the patients of all groups were satisfied or very satisfied.;Expected outcome 2: Frequency and severity of adverse events.;Observed outcome 2: No treatment-related adverse events (0%) were reported by the patients or noticed by the investigators with the proposed techniques and doses. | — |
Countries
Brazil
Contacts
Public ContactCarolina Siega
Centro Brasileiro de Estudos em Dermatologia
Outcome results
None listed