CompletedPhase 1/2

Higher Doses of Botulinum Toxin in the Treatment of Gummy Smile

China33 participantsStarted 2019-11-20

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Anterior Gingival Exposure (GE) 4 Weeks Post-injection

Timeframe: 4 weeks postinjection

Trial details

NCT IDNCT05127018

SponsorPeking University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-08-20

Results submitted2022-09-27

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