Clinical trial NCT06075134: EMG-guided Botox Injection Versus Conventional Botox Injection in Gummy Smile Patients
Official title: EMG-guided Botox Injection Versus Conventional Injection in Yonsei Point in Gummy Smile Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Excessive Gingival Display
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 32
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 goal of this clinical trial is to compare the effect of EMG-guided Botox injection with conventional Botox injection in Yonsei point, in patients with excessive gingival display.

The main question it aims to answer is:

• Does the use of electromyography (EMG) as a guide during Botox injection for patients with gummy smile has better effect than conventional injection in Yonsei point?

Participants will be randomized in equal proportions between intervention and control groups.

* Preoperative assessment of amount of gingival display, lip length (philtrum and vermilion length), and smile type.
* For the intervention group, EMG readings will be done in Clinical Neurophysiology Department, Kasr Al-Ainy Hospital EMG-guided Botox injection (Intervention group). Conventional Botox injection in Yonsei point (Control group).


Eligibility criteria: Inclusion Criteria:

* Patients with excessive gingival display.
* Patients with esthetic concerns.
* Patients with mild to moderate VME (vertical maxillary excess).
* Normal clinical crown dimensions.
* Patients aged 18 to 50.
* Systemically healthy patients.
* Non-smokers.

Exclusion Criteria:

* Patients with severe VME (vertical maxillary excess).
* Pregnant and breastfeeding women.
* Patients with gingival inflammation and/or enlargement.
* Inflammation or infection at the site of injection.
* Patients with known allergy to any of the components of Botox (i.e., saline, human albumin, lactose and sodium succinate).
* Patients using anticholinesterase or other agents affecting neuromuscular transmission.
* Psychologically unstable patients or those who have unrealistic expectations and questionable motives.
* Patients with neuromuscular disorders (e.g., myasthenia gravis, Eaton-Lambert syndrome).

Primary outcomes:
measure: Change in amount of gingival display
timeFrame: Baseline, One-week, One-month, three-months, and six-months follow-up
Secondary outcomes:
measure: Quantitative EMG
timeFrame: Baseline, One-week and six-months follow-up
measure: Patient satisfaction
timeFrame: Baseline, One-week, One-month, three-months, and six-months follow-up
measure: Post-operative pain
timeFrame: Baseline, One-week, and One-month follow-up
measure: Smile type
timeFrame: Baseline, One-week, One-month, three-months, and six-months follow-up
measure: Change in lip length
timeFrame: Baseline, One-week, One-month, three-months, and six-months follow-up
measure: Esthetics (Symmetry) for operators
timeFrame: Baseline, One-week, One-month, three-months, and six-months follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Sherry Fayez Akhnokh, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Noha Ghallab, PhD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Nesma Shemais, PhD
role: STUDY_CHAIR
References: