NCT03812965

Botulinum Toxin in the Treatment of Gingival Smile

Effectiveness and Durability of Botulinum Toxin Application in the Treatment of Gingival Smile

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Universidade Ibirapuera · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Botulinum toxin type A	2 units/point of botulinum toxin type A

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-02-08
• Completion: 2019-04-08
• First posted: 2019-01-23
• Last updated: 2019-06-05

Locations

1 site across 1 country: Brazil