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Botulinum Toxin in the Treatment of Gingival Smile

NCT03812965 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-06-05

No results posted yet for this study

Summary

Objective: to evaluate the effect of two gingival smile treatment techniques using botulinum toxin. Materials and methods: The randomized, double-blind clinical trial (patient and examiner) will be conducted by two trained and calibrated dentists. Ten patients will be randomly assigned to each group, in a total of 20 patients with gingiva smile greater than or equal to 3mm. In group 1, 10 patients will receive 2 units/point of botulinum toxin Botulift® (botulinum toxin type A), in the muscles form the face: Levators labii superioris alaeque nasi muscle and Levators labii superioris muscle, totalizing 4 points. In group 2, 2 units/point was injected in the muscles: levators labii superioris alaeque nasi muscle, totalizing 2 points. The amount of exposed gingiva during smile will be measured using a pachymeter and the muscle activity of the region will be evaluated through electromyography, before and after treatment (2, 8, 12, 21 and 25 weeks). Patient satisfaction and discomfort due to treatment will be evaluated in the same periods through questionnaire. The impact of the treatment in life quality will be evaluated through OHIP-14 questionnaire.

Conditions

  • Smiling

Interventions

DRUG

Botulinum toxin type A

2 units/point of botulinum toxin type A

Sponsors & Collaborators

  • Universidade Ibirapuera

    lead OTHER

Principal Investigators

  • Aline B Costa, DDS · Ibirapuera University

  • Dinete Romansina, MSc · University of Sao Paulo

  • Juliana Ramalho, DDS · Ibirapuera University

  • Karen M Ramalho, PhD · Ibirapuera University

  • Susana Morimoto, PhD · Ibirapuera University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2019-02-08
Completion
2019-04-08

Countries

  • Brazil

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 NCT03812965 on ClinicalTrials.gov