Botulinum Toxin in the Treatment of Gingival Smile

Smiling Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03812965
• Other study ID #: 80103617.0.0000.5597
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2018
• Est. completion date: April 8, 2019

Study information

• Verified date: June 2019
• Source: Universidade Ibirapuera
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 8, 2019
• Est. primary completion date: February 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Smiling

Intervention

Drug:
• Botulinum toxin type A
2 units/point of botulinum toxin type A

Locations

Country	Name	City	State
Brazil	Universidade Ibirapuera	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Ibirapuera

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exposed Gingiva during Smile (mm)	Measurement of exposed gingiva during smile using a pachymeter	Before Treatment
Primary	Exposed Gingiva during Smile (mm)	Measurement of exposed gingiva during smile using a pachymeter	After Treatment (2 weeks)
Primary	Exposed Gingiva during Smile (mm)	Measurement of exposed gingiva during smile using a pachymeter	After Treatment (8 weeks)
Primary	Exposed Gingiva during Smile (mm)	Measurement of exposed gingiva during smile using a pachymeter	After Treatment (12 weeks)
Primary	Exposed Gingiva during Smile (mm)	Measurement of exposed gingiva during smile using a pachymeter	After Treatment (21 weeks)
Primary	Exposed Gingiva during Smile (mm)	Measurement of exposed gingiva during smile using a pachymeter	After Treatment (25 weeks)
Secondary	Muscles Activity	Muscles activity using electromyography	Before Treatment
Secondary	Muscles Activity	Muscles activity using electromyography	After Treatment (2 weeks)
Secondary	Muscles Activity	Muscles activity using electromyography	After Treatment (8 weeks)
Secondary	Muscles Activity	Muscles activity using electromyography	After Treatment (12 weeks)
Secondary	Muscles Activity	Muscles activity using electromyography	After Treatment (21 weeks)
Secondary	Muscles Activity	Muscles activity using electromyography	After Treatment (25 weeks)