EMG-guided Botox Injection Versus Conventional Botox Injection in Gummy Smile Patients

Study Overview
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Brief Summary
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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).

Official Title
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EMG-guided Botox Injection Versus Conventional Injection in Yonsei Point in Gummy Smile Patients: A Randomized Clinical Trial

Conditions
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Excessive Gingival Display

Intervention / Treatment
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* Procedure: Botox injection
* Device: EMG
* Drug: Zinc Supplement


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMG-guided Botox injection<br>Botox injection in patients with gummy smile will be done under electromyography guidance to target the most hyperactive and effective muscle that is the chief factor causing the condition. | Procedure: Botox injection<br>* Botox injection<br>* Other names: Botulinum toxin injection;Device: EMG<br>* Quantitative Electromyography<br>* Other names: Electromyography;Drug: Zinc Supplement<br>* To increase efficacy of Botox<br>* Other names: Zinc supplement in the form of tablets;|
| Active Comparator: Conventional Botox injection in Yonsei point<br>Conventional injection of Botox is located in Yonsei point, which is the center of a triangle formed by the convergence of Levator labii superioris alaeque nasi (LLSAN), levator labii superioris (LLS), zygomaticus minor (ZMn), muscles, and is located 1 cm lateral to the ala of the nose horizontally and 3 cm above the lip line vertically. | Procedure: Botox injection<br>* Botox injection<br>* Other names: Botulinum toxin injection;Drug: Zinc Supplement<br>* To increase efficacy of Botox<br>* Other names: Zinc supplement in the form of tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in amount of gingival display | Will be measured using ruler in mm. | Baseline, One-week, One-month, three-months, and six-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative EMG | Will be measured using EMG in mv. | Baseline, One-week and six-months follow-up | 
| Patient satisfaction | Will be assessed using questionnaire, on a scale from 1 to 5, where 1 is completely not satisfied and 5 is completely satisfied. | Baseline, One-week, One-month, three-months, and six-months follow-up | 
| Post-operative pain | Will be measured using visual analogue scale (VAS) from 1 to 10. | Baseline, One-week, and One-month follow-up | 
| Smile type | Qualitative, by Rubin (1974). Smile is classified into 1. Corner of the mouth (Mona Lisa) smile, 2. Canine Smile, and 3. Full denture smile | Baseline, One-week, One-month, three-months, and six-months follow-up | 
| Change in lip length | Will be measured using UNC (University of North Carolina) -15 periodontal probe in mm. | Baseline, One-week, One-month, three-months, and six-months follow-up | 
| Esthetics (Symmetry) for operators | Will be measured using 5-point Likert scale, where 1 is significantly asymmetrical and 5 is completely symmetrical. | Baseline, One-week, One-month, three-months, and six-months follow-up |