Botulinum Toxin in the Treatment of Gingival Smile

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

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.

Study Overview

• Status: Completed
• Conditions: Smiling
• Intervention / Treatment: Drug: Botulinum toxin type A

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 04661-100
      • Universidade Ibirapuera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 - Botulinum Toxin type A (4 points of application); 4 points of Botulinum Toxin application in the muscles: Levators labii superioris alaeque nasi muscle and Levators labii superioris muscle (n=10 Patients)	Drug: Botulinum toxin type A; 2 units/point of botulinum toxin type A
Experimental: Group 2 - - Botulinum Toxin type A (2 points of application); 2 points of Botulinum Toxin application in the muscles: Levators labii superioris alaeque nasi muscle (n=10 Patients)	Drug: Botulinum toxin type A; 2 units/point of botulinum toxin type A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exposed Gingiva during Smile (mm)	Measurement of exposed gingiva during smile using a pachymeter	Before Treatment
Exposed Gingiva during Smile (mm)	Measurement of exposed gingiva during smile using a pachymeter	After Treatment (2 weeks)
Exposed Gingiva during Smile (mm)	Measurement of exposed gingiva during smile using a pachymeter	After Treatment (8 weeks)
Exposed Gingiva during Smile (mm)	Measurement of exposed gingiva during smile using a pachymeter	After Treatment (12 weeks)
Exposed Gingiva during Smile (mm)	Measurement of exposed gingiva during smile using a pachymeter	After Treatment (21 weeks)
Exposed Gingiva during Smile (mm)	Measurement of exposed gingiva during smile using a pachymeter	After Treatment (25 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscles Activity	Muscles activity using electromyography	Before Treatment
Muscles Activity	Muscles activity using electromyography	After Treatment (2 weeks)
Muscles Activity	Muscles activity using electromyography	After Treatment (8 weeks)
Muscles Activity	Muscles activity using electromyography	After Treatment (12 weeks)
Muscles Activity	Muscles activity using electromyography	After Treatment (21 weeks)
Muscles Activity	Muscles activity using electromyography	After Treatment (25 weeks)

Collaborators and Investigators

• Sponsor: Universidade Ibirapuera
• Investigators: Study Chair: Aline B Costa, DDS, Ibirapuera University; Study Chair: Dinete Romansina, MSc, University of Sao Paulo; Study Chair: Juliana Ramalho, DDS, Ibirapuera University; Principal Investigator: Karen M Ramalho, PhD, Ibirapuera University; Study Chair: Susana Morimoto, PhD, Ibirapuera University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): February 8, 2019
• Study Completion (Actual): April 8, 2019

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: January 20, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): June 5, 2019
• Last Update Submitted That Met QC Criteria: June 4, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Botulinum Toxin; Gingival Smile
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 80103617.0.0000.5597

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No