跳至主要内容
临床试验/NCT06148961
NCT06148961进行中(未招募)不适用

Effect of Botox Before Modified Lip Repositioning and Modified Lip Repositioning Only in Relapse of the Excessive Gingival Display Within One Year

Cairo University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
20
试验地点
2
主要终点
Change in gingival display

研究概览

简要总结

The growing interest of patients in esthetic procedures, as well as the development of less invasive protocols in dentistry, has promoted the development of treatment plans that include stability, harmony, and function in orofacial rehabilitation.

Poor esthetics interfere with an individual's personal, social, and professional relationships and is an individual consideration that varies according to the patient's age, time, region, and culture concerning what is considered beautiful.

详细描述

People are increasingly being inspired to get more corrective and cosmetic surgeries as an esthetic smile becomes a more fundamental component of what it means to be beautiful.

There are several variables that affect how appealing and esthetic a smile is Esthetic perception varies according to cultural, societal, environmental, and individual factors like experience and educational level Previous studies have shown that a smile with less gingival display (GD) is viewed as more beautiful, with dental professionals being more critical of gingival presentation than laypeople According to research by several authors, the ideal GD ranges from 1 to 3 mm While many factors influence how pleasant a smile is seen, excessive GD (EGD), sometimes referred to as a gummy smile, is regarded as a key factor in smile analysis and one of the main issues connected to an unsatisfactory dental smile.

To reduce the relapse associated with repositioning surgery and to provide a lasting treatment without the need for reapplication, as in the case of the toxin, a combined treatment using the toxin preoperatively was considered.

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

入选标准

  • Patients that is not satisfied with his smile having excessive gingival display
  • Adult Age ≥ 21 years.
  • Systemically and periodontally Healthy patients.
  • had gingival exposure greater than 3 mm when smiling
  • had a hyperactive upper lip with or without other causes of EGD (lip displacement ≥ 9 mm) before botox & ≥ 3mm after.
  • Cooperative patients able and accept to come for follow up appointments.

排除标准

  • • smoking
  • pregnancy or lactation
  • Systemic diseases; neuromuscular,neurological, or psychological disorders or consumption of controlled medication
  • Patients having medical condition or any drugs that could affect healing
  • Patients with systemic condition that can't undergo minor oral surgery
  • Patient allergic to Botox or multiple allergic conditions
  • have history of previous Botox injection
  • periodontal disease
  • excessive gingival display at rest
  • those who declined the informed consent or who did not consent to the risks described.
  • Those who have deviate smile

研究组 & 干预措施

intervention group

Experimental

botox injection prior to surgical intervention by 5 to 10 days A surgical marker was used to outline the boundaries of the surgical incision region.

the height of the superior incision was measured as 15 mm within the vestibule. Superior and inferior incisions were made with a scalpel blade number 15 and linked bilaterally by two vertical incisions.

A partial thickness dissection was used to remove the strip of the indicated mucosa, exposing the fascia of the connective tissue beneath. When necessary, all salivary glands and frenal attachments were removed. The surgical site was then properly closed using a periosteal simple interrupted suture was put in place prior to the continuous interlocking sutures. It was placed by commencing the needle 2 mm coronal to Per surgery site, 3 to 4 periosteal sutures were typically The new mucosal boundary to the gingiva was stabilized in its new place using this suture

干预措施: botox prior to modified lip repostioning (Procedure)

control group

Active Comparator

A surgical marker was used to outline the boundaries of the surgical incision region.

the height of the superior incision was measured as 15 mm within the vestibule. Superior and inferior incisions were made with a scalpel blade number 15 and linked bilaterally by two vertical incisions.

A partial thickness dissection was used to remove the strip of the indicated mucosa, exposing the fascia of the connective tissue beneath. When necessary, all salivary glands and frenal attachments were removed. The surgical site was then properly closed using a periosteal simple interrupted suture was put in place prior to the continuous interlocking sutures. It was placed by commencing the needle 2 mm coronal to Per surgery site, 3 to 4 periosteal sutures were typically The new mucosal boundary to the gingiva was stabilized in its new place using this suture

干预措施: botox prior to modified lip repostioning (Procedure)

结局指标

主要结局

Change in gingival display

时间窗: 3,6&12 months

Using a 15-cm marked ruler (Antunes et al., 2022)

次要结局

  • Patient's satisfaction(3,6 &12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cherine Emad Mahmoud Mohamed Hamada

assistant lecturer

October University for Modern Sciences and Arts

研究点 (2)

Loading locations...

相似试验