Botulinum Toxin in the Treatment of Gingival Smile

Phase 2

Completed

• Conditions: Smiling
• Interventions: Drug: Botulinum toxin type A

• Registration Number: NCT03812965
• Lead Sponsor: Universidade Ibirapuera

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-01-20
• Study First Posted: 2019-01-23
• Primary Completion: 2019-02-08
• Study Completion: 2019-04-08
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-04
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients of both genders exhibiting gingival exposure greater than or equal to 3 mm above the central incisor during smile
2. Patients with good general health and good oral hygiene.

Exclusion Criteria

1. Patients with Botulinum Toxin allergy or albumin, or who have previously performed botulinum toxin facial treatment previously.
2. Patients with Amyotrophic Lateral Sclerosis, Neuropathy, Myasthenia Gravis or Lambert-Eaton Syndrome, women who are pregnant or planning to become pregnant, are breastfeeding women.
3. Patients who are participating in other research involving other drugs.
4. Patients who use drugs that interfere with neuromuscular transmission

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 - Botulinum Toxin type A (4 points of application)	Botulinum toxin type A	4 points of Botulinum Toxin application in the muscles: Levators labii superioris alaeque nasi muscle and Levators labii superioris muscle (n=10 Patients)
Group 2 - - Botulinum Toxin type A (2 points of application)	Botulinum toxin type A	2 points of Botulinum Toxin application in the muscles: Levators labii superioris alaeque nasi muscle (n=10 Patients)

Primary Outcome Measures

Name	Time	Method
Exposed Gingiva during Smile (mm)	After Treatment (25 weeks)	Measurement of exposed gingiva during smile using a pachymeter

Secondary Outcome Measures

Name	Time	Method
Muscles Activity	After Treatment (25 weeks)	Muscles activity using electromyography

Trial Locations

Locations (1)

Universidade Ibirapuera; 🇧🇷 São Paulo, SP, Brazil