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Active, Not Recruiting

NCT Number: NCT06148961

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Excessive Gingival Display

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cherine Emad Mahmoud Mohamed Hamada

Giza, 12566, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

botox prior to modified lip repostioning

Procedure

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

Primary outcomes

  1. Change in gingival display

    Time frame: 3,6&12 months

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

Secondary outcomes

  1. Patient's satisfaction

    Time frame: 3,6 &12 months

    Survey (Silva et al., 2013)

Other outcomes

  1. Maintenance of reduction of gingival display

    Time frame: 3 , 6 & 12 months

    callipper

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 28, 2023
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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