Clinical trial NCT03812965: Botulinum Toxin in the Treatment of Gingival Smile
Official title: Effectiveness and Durability of Botulinum Toxin Application in the Treatment of Gingival Smile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smiling
Keywords: Botulinum Toxin
Gingival Smile
Lead sponsor: Universidade Ibirapuera
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Exposed Gingiva during Smile (mm)
timeFrame: Before Treatment
measure: Exposed Gingiva during Smile (mm)
timeFrame: After Treatment (2 weeks)
measure: Exposed Gingiva during Smile (mm)
timeFrame: After Treatment (8 weeks)
measure: Exposed Gingiva during Smile (mm)
timeFrame: After Treatment (12 weeks)
measure: Exposed Gingiva during Smile (mm)
timeFrame: After Treatment (21 weeks)
measure: Exposed Gingiva during Smile (mm)
timeFrame: After Treatment (25 weeks)
Secondary outcomes:
measure: Muscles Activity
timeFrame: Before Treatment
measure: Muscles Activity
timeFrame: After Treatment (2 weeks)
measure: Muscles Activity
timeFrame: After Treatment (8 weeks)
measure: Muscles Activity
timeFrame: After Treatment (12 weeks)
measure: Muscles Activity
timeFrame: After Treatment (21 weeks)
measure: Muscles Activity
timeFrame: After Treatment (25 weeks)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Ibirapuera
state: SP
Study officials:
affiliation: Ibirapuera University
name: Aline B Costa, DDS
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Dinete Romansina, MSc
role: STUDY_CHAIR
affiliation: Ibirapuera University
name: Juliana Ramalho, DDS
role: STUDY_CHAIR
affiliation: Ibirapuera University
name: Karen M Ramalho, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ibirapuera University
name: Susana Morimoto, PhD
role: STUDY_CHAIR
References: