EMG-guided Botox Injection Versus Conventional Injection in Yonsei Point in Gummy Smile Patients: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in amount of gingival display
研究概览
简要总结
The goal of this clinical trial is to compare the effect of EMG-guided Botox injection with conventional Botox injection in Yonsei point, in patients with excessive gingival display.
The main question it aims to answer is:
• Does the use of electromyography (EMG) as a guide during Botox injection for patients with gummy smile has better effect than conventional injection in Yonsei point?
Participants will be randomized in equal proportions between intervention and control groups.
- Preoperative assessment of amount of gingival display, lip length (philtrum and vermilion length), and smile type.
- For the intervention group, EMG readings will be done in Clinical Neurophysiology Department, Kasr Al-Ainy Hospital EMG-guided Botox injection (Intervention group). Conventional Botox injection in Yonsei point (Control group).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with excessive gingival display.
- •Patients with esthetic concerns.
- •Patients with mild to moderate VME (vertical maxillary excess).
- •Normal clinical crown dimensions.
- •Patients aged 18 to
- •Systemically healthy patients.
- •Non-smokers.
排除标准
- •Patients with severe VME (vertical maxillary excess).
- •Pregnant and breastfeeding women.
- •Patients with gingival inflammation and/or enlargement.
- •Inflammation or infection at the site of injection.
- •Patients with known allergy to any of the components of Botox (i.e., saline, human albumin, lactose and sodium succinate).
- •Patients using anticholinesterase or other agents affecting neuromuscular transmission.
- •Psychologically unstable patients or those who have unrealistic expectations and questionable motives.
- •Patients with neuromuscular disorders (e.g., myasthenia gravis, Eaton-Lambert syndrome).
研究组 & 干预措施
EMG-guided Botox injection
Botox injection in patients with gummy smile will be done under electromyography guidance to target the most hyperactive and effective muscle that is the chief factor causing the condition.
干预措施: EMG (Device)
EMG-guided Botox injection
Botox injection in patients with gummy smile will be done under electromyography guidance to target the most hyperactive and effective muscle that is the chief factor causing the condition.
干预措施: Zinc Supplement (Drug)
EMG-guided Botox injection
Botox injection in patients with gummy smile will be done under electromyography guidance to target the most hyperactive and effective muscle that is the chief factor causing the condition.
干预措施: Botox injection (Procedure)
Conventional Botox injection in Yonsei point
Conventional injection of Botox is located in Yonsei point, which is the center of a triangle formed by the convergence of Levator labii superioris alaeque nasi (LLSAN), levator labii superioris (LLS), zygomaticus minor (ZMn), muscles, and is located 1 cm lateral to the ala of the nose horizontally and 3 cm above the lip line vertically.
干预措施: Botox injection (Procedure)
Conventional Botox injection in Yonsei point
Conventional injection of Botox is located in Yonsei point, which is the center of a triangle formed by the convergence of Levator labii superioris alaeque nasi (LLSAN), levator labii superioris (LLS), zygomaticus minor (ZMn), muscles, and is located 1 cm lateral to the ala of the nose horizontally and 3 cm above the lip line vertically.
干预措施: Zinc Supplement (Drug)
结局指标
主要结局
Change in amount of gingival display
时间窗: Baseline, One-week, One-month, three-months, and six-months follow-up
Will be measured using ruler in mm.
次要结局
- Quantitative EMG(Baseline, One-week and six-months follow-up)
- Smile type(Baseline, One-week, One-month, three-months, and six-months follow-up)
- Post-operative pain(Baseline, One-week, and One-month follow-up)
- Change in lip length(Baseline, One-week, One-month, three-months, and six-months follow-up)
- Patient satisfaction(Baseline, One-week, One-month, three-months, and six-months follow-up)
- Esthetics (Symmetry) for operators(Baseline, One-week, One-month, three-months, and six-months follow-up)
研究者
Sherry Fayez Akhnokh
Periodontology Resident
Cairo University