Clinical trial NCT06148961: Effect of Botox Before Modified Lip Repositioning Repositioning Only in Relapse of the Excessive Gingival Display Within One Year
Official title: Effect of Botox Before Modified Lip Repositioning and Modified Lip Repositioning Only in Relapse of the Excessive Gingival Display Within One Year
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Excessive Gingival Display
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* • 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

Primary outcomes:
measure: Change in gingival display
timeFrame: 3,6&12 months
Secondary outcomes:
measure: Patient's satisfaction
timeFrame: 3,6 &12 months
Other outcomes:
measure: Maintenance of reduction of gingival display
timeFrame: 3 , 6 & 12 months
Locations:
city: Giza
country: Egypt
facility: Cherine Emad Mahmoud Mohamed Hamada
Study officials:
References: