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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Excessive Gingival Display

Treatments: Procedure: Botox injection; Drug: Zinc Supplement; Device: EMG

Study type: Interventional

Funder types: Other

Identifiers

NCT06075134

SFAkhnokh

Details and patient eligibility

About

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).

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

EMG-guided Botox injection

Experimental group

Description:

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.

Treatment:

Drug: Zinc Supplement

Device: EMG

Procedure: Botox injection

Conventional Botox injection in Yonsei point

Active Comparator group

Description:

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.

Treatment:

Drug: Zinc Supplement

Procedure: Botox injection