Effectiveness and Durability of Botulinum Toxin Application in the Treatment of Gingival Smile
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Exposed Gingiva during Smile (mm)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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)
干预措施: Botulinum toxin type A (Drug)
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)
干预措施: Botulinum toxin type A (Drug)
结局指标
主要结局
Exposed Gingiva during Smile (mm)
时间窗: After Treatment (25 weeks)
Measurement of exposed gingiva during smile using a pachymeter
次要结局
- Muscles Activity(After Treatment (25 weeks))
研究者
Karen Müller Ramalho
Full Professor
Universidade Ibirapuera