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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03812965
Study type Interventional
Source Universidade Ibirapuera
Contact
Status Completed
Phase Phase 2
Start date August 1, 2018
Completion date April 8, 2019

See also
  Status Clinical Trial Phase
Completed NCT04527744 - Application of Botulinum Toxin at the Yonsei Point for the Treatment of Gummy Smile N/A
Completed NCT05127018 - Higher Doses of Botulinum Toxin in the Treatment of Gummy Smile Phase 1/Phase 2
Completed NCT04820543 - Effects of Dose and Injection Site for Gummy Smile Treatment With Botulinum Type A Phase 4