Botulinum Toxin in the Treatment of Gingival Smile

NCT03812965 | Completed Phase 2

• 1 other identifier: 80103617.0.0000.5597
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Smiling

Keywords

Botulinum Toxin; Gingival Smile

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Muscles Activity

  Before Treatment

• Muscles Activity

  After Treatment (2 weeks)

• Muscles Activity

  After Treatment (8 weeks)

• Muscles Activity

  After Treatment (12 weeks)

• Muscles Activity

  After Treatment (21 weeks)

Study Arms (2)

Group 1 - Botulinum Toxin type A (4 points of application)

EXPERIMENTAL

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

Group 2 - - Botulinum Toxin type A (2 points of application)

EXPERIMENTAL

2 points of Botulinum Toxin application in the muscles: Levators labii superioris alaeque nasi muscle (n=10 Patients)

Drug: Botulinum toxin type A

Interventions

Botulinum toxin type A DRUG

2 units/point of botulinum toxin type A

Group 1 - Botulinum Toxin type A (4 points of application); Group 2 - - Botulinum Toxin type A (2 points of application)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Ibirapuera: lead

Study Sites (1)

Universidade Ibirapuera

São Paulo, São Paulo, 04661-100, Brazil

Location

MeSH Terms

Conditions

Smiling

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Facial Expression; Nonverbal Communication; Communication; Behavior

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Aline B Costa, DDS

  Ibirapuera University

  STUDY CHAIR

• Dinete Romansina, MSc

  University of Sao Paulo

  STUDY CHAIR

• Juliana Ramalho, DDS

  Ibirapuera University

  STUDY CHAIR

• Karen M Ramalho, PhD

  Ibirapuera University

  PRINCIPAL INVESTIGATOR

• Susana Morimoto, PhD

  Ibirapuera University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 23, 2019
• Study Start: August 1, 2018
• Primary Completion: February 8, 2019
• Study Completion: April 8, 2019
• Last Updated: June 5, 2019

Record last verified: 2019-06

Locations

BR (1)