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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Drug | 2 units/point of botulinum toxin type A |
|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Muscles Activity | Muscles activity using electromyography | Before Treatment |
| Muscles Activity | Muscles activity using electromyography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Ibirapuera | São Paulo | São Paulo | 04661-100 | Brazil |
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| ID | Term |
|---|---|
| D012904 | Smiling |
| ID | Term |
|---|---|
| D005149 | Facial Expression |
| D009633 | Nonverbal Communication |
| D003142 | Communication |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| 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) |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |