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

Not Applicable

Not yet recruiting

• Conditions: Excessive Gingival Display
• Interventions: Procedure: Botox injection; Device: EMG; Drug: Zinc Supplement

• Registration Number: NCT06075134
• Lead Sponsor: Cairo University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-26
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-03
• Last Update Submitted: 2023-10-03
• Study First Posted: 2023-10-10
• Last Update Posted: 2023-10-10
• Study Start: 2023-11
• Primary Completion: 2024-06
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMG-guided Botox injection	Zinc Supplement	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.
EMG-guided Botox injection	EMG	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.
Conventional Botox injection in Yonsei point	Botox injection	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.
EMG-guided Botox injection	Botox injection	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.
Conventional Botox injection in Yonsei point	Zinc Supplement	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.

Primary Outcome Measures

Name	Time	Method
Change in amount of gingival display	Baseline, One-week, One-month, three-months, and six-months follow-up	Will be measured using ruler in mm.

Secondary Outcome Measures

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