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Effects of Dose and Injection Site for Gummy Smile Treatment With Botulinum Type A

NCT04820543 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2021-04-01

No results posted yet for this study

Summary

Botulinum type A (BTX-A) is an easy and efficacious treatment for gingival smile (GS). However, its dosage and injection sites effect among patients are controversial.The objective was to compare the reduction of gingival exposure using two methods in patients with different dosage and injection sites. 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 single-point injection of 2 U BTX-A per side in the Simplified Method. And after 8 months, the Individualized Method was administered with 2-5 U BTX-A (total, 4-10 U) injections into 1-2 points according to the severity presented pretreatment. Data were collected at baseline and 4, 12, and 32 weeks of follow-up.

Conditions

  • Smiling
  • Botulinum Toxins, Type A

Interventions

DRUG

injection of Botulinum type A

The participates were allocated to two different application methods: Simplified Method for the first injection and Individualized Method 8 months later. All the patients underwent twice injection with each methods with no change of the BTX-A(Botox, Allergan, Irvine, CA) and other injection details: Lyophilized 100 U of Botox was reconstituted in 2.5 mL of 0.9% sodium chloride solution. The injections were made with a 27-gauge insulin syringe. The treatment was an outpatient procedure and all injections were performed by one of the authors (X.G.). No anesthesia was given during the procedure.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-20
Primary Completion
2019-11-20
Completion
2020-06-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04820543 on ClinicalTrials.gov