Comparison of effectiveness, duration and patient’s satisfaction of Botulinum toxin A and Hyaluronic filler in the treatment of gummy smile :An in-vivo study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- To evaluate the effectiveness, duration and patients satisfaction by Botulinum Toxin A and Hyaluronic filler in gummy smile patients
研究概览
简要总结
This study is a randomised, double- blinded,before and after study, a prospective study,an experimental comparative, clinical study. The study is to compare Botox -A and Hyaluronic acid filler when given as an adjunct to orthodontic treatment to improve the smile esthetics. Primary outcome is to compare the effectiveness of Botulinum toxin A and Hyaluronic filler in the treatment of gummy smile. Secondary outcomes are to assess immediate effectiveness of botox-A and Hyaluronic acid filler on 14th day , to assess the stability of gummy smile correction post administration of Botox-A and Hyaluronic acid Filler on 30th , 60 the , and 90th day , to evaluate patients satisfaction post administration of Botox-A and Hyaluronic acid Filler and to assess the gingival display pre and post administration of Botox-A and Hyaluronic acid filler
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Patients with gummy smile more than 3 mm.
- •â€¢ No history of previous treatment for correction of gummy smile.
- •â€¢ Patients wanting aesthetic smile correction without surgery.
排除标准
- •1.History of neuromuscular disorder
- •Patients allergic to Botolium toxin A and B
- •Patients taking medications that might interfere with the neuromuscular impulse transmission and potentiate the effects of Botolium toxin.
- •Patients who are mentally / physically not stable.
结局指标
主要结局
To evaluate the effectiveness, duration and patients satisfaction by Botulinum Toxin A and Hyaluronic filler in gummy smile patients
时间窗: Each patient will be observed for 3months for the study purpose
次要结局
- To assess the effectiveness in correction of gummy smile post administration of botox A immediately after 14th day(1month)
- To assess the effectiveness in correction of gummy smile post administration of Hyaluronic acid Filler immediately after 14th day(1month)
- To access the stability of duration of gummy smile correction, post-administration of Botox ‑A at the end of 30th , 60th and 90th day.(1 month)
- To access the stability of duration of gummy smile correction, post-administration of Hyaluronic acid Filler at the end of 30th , 60th and 90th day.(1 month)
- To assess the gingival display pre and post treatment after administration of Botox -A(3 months)
- To assess the gingival display pre and post treatment after administration of Hyaluronic acid filler(3 months)
- To evaluate patients satisfaction in administration of Botox -A(3 months)
- To evaluate patients satisfaction in administration of Hyaluronic acid filler(3 months)
研究者
Dr Truppti P Sonone
D.Y.Patil School of Dentistry, Nerul, Navi Mumbai