Phase 2
N=33
Higher Doses of Botulinum Toxin in the Treatment of Gummy Smile
Smiling · Botulinum Toxins, Type A
Bottom Line
View on ClinicalTrials.gov: NCT05127018 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Anterior Gingival Exposure (GE) 4 Weeks Post-injection — 3.6; 3.0 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- injection of Botulinum type A (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Peking University
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anterior Gingival Exposure (GE) 4 Weeks Post-injection |
3.6; 3.0 | — |
| SECONDARY Anterior Gingival Exposure (GE) 12 Weeks Post-injection |
5.4; 4.9 | — |
| SECONDARY Anterior Gingival Exposure (GE) 24 Weeks Post-injection |
6.3; 5.8 | — |
| SECONDARY Anterior Gingival Exposure (GE) 48 Weeks Post-injection |
7.0; 6.5 | — |
Summary
Botulinum type A (BTX-A) is an easy and efficacious treatment for gingival smile (GS). However, the necessary for higher-doses among patients are controversial. The objective was to compare the reduction of gingival exposure using two methods in patients with different dosage. In this prospective self-controlled study, healthy GS participates who had an anterior gingival exposure (GE) of more than 3 mm were enrolled and administered with 2-5 U BTX-A (total, 4-10 U) injections into 1-2 points according to the severity presented pretreatment in the Average-dose Method. And after 8 months, the Higher-doses Method was administered the same point injection of 3-10 U BTX-A (total, 6-20 U). Data were collected at baseline and 4, 12, 32 and 60 weeks of follow-up.
Eligibility Criteria
Inclusion Criteria
- ≥ 3.0-mm anterior gingival exposure upon unrestricted, "full-blown" smiling
- healthy adults
Exclusion Criteria
- contraindication of BTX-A
- previous diseases or treatments affecting the position of the gingiva or upper lips
- history of BTX-A injections to the head or neck region
- facial paralysis
- having received and/or receiving active orthodontic treatment that includes vertical dimension treatment, such as extrusion and intrusion, and presence of
- periodontal disease
- subject's refusal to participate
Data sourced from ClinicalTrials.gov (NCT05127018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.