Satisfaction Of Adult Patients With Gummy Smile Treated By Botulinum Toxin A Injection Versus Modified Lip Repositioning Surgery : A Randomized Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 22
- 主要终点
- Patient satisfaction and postoperative side effects
研究概览
简要总结
The aim of the proposal study is to answer the question of how to manage gummy smiles due to hypermobile upper lip with less invasive and low risk level procedure . This trial will help the practitioners and the patients in taking the convenient decision to correct the gumminess to restore lip-gingival-dental harmony and enhance smile asthetics.
详细描述
In this randomized clinical trial , two groups will be included to compare the effectiveness of a treatment modality of botulinum toxin-A injection , in the first group , on gingival display during smiling ,patient satisfaction , lower face esthetics ( upper lip length , upper lip vermillion length , interlabial gap , nasolabial angle) and the postoperative side effects . the comparator group will receive treatment by modified lip repositioning surgery ,to compare the results of the intervention group that can possibly obtained without undergoing surgery.
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)
盲法说明
single blind
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults with age range from 18 - 30 years.
- •Excessive gingival display more than 3 mm during smiling.
- •Patients having hypermobile upper lip with or without (mild / moderate) vertical maxillary excess.
- •Patients with normal morphology of clinical crowns.
- •Normal lip separation (ILG) at rest
- •Medically free subjects.
排除标准
- •Patients with systemic diseases or neuromuscular disorders.
- •Gummy smile with gingival display more than 8 mm during smiling.
- •Severly long face (VME) patients.
- •Patients with periodontal disease or gingival hyperplasia .
- •Medically compromised patients contraindicated for surgery .
- •Pregnant or lactating female patients.
- •Patients with inadequate attached gingiva .
研究组 & 干预措施
Botulinum Toxin A Injection
this group will receive Botulinum Toxin A Injection at doses of 2.5 or 5 IU (depending on the degree of gum exposure) on each side of the nasolabial fold with follow up at at 2,4,8,12 and 24 weeks.
干预措施: Botulinum Toxin A Injection (Drug)
Modified Lip Repositioning Surgery
this group will receive Modified Lip Repositioning Surgery with follow up at at 2,4,8,12 and 24 weeks.
干预措施: Modified Lip Repositioning Surgery (Procedure)
结局指标
主要结局
Patient satisfaction and postoperative side effects
时间窗: at 4 weeks
it will be assessed using Questionnaire.
次要结局
- Lower face esthatics: a) upper lip length b) upper lip- vermillion length c) interlabial gap(at 4,8 and 12 weeks)
- stability of gummy smile correction.(at the end of 24 weeks.)
- Lower face esthatics: d)nasolabial angle(at 4,8 and 12 weeks)
- Improvement of gingival display upon smiling(at 4,8 and 12 weeks)
研究者
Zeinab mohamed
principal investigator
Cairo University