EMG-guided Botox Injection Versus Conventional Botox Injection in Gummy Smile Patients
Study Details
Study Description
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.
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Preoperative assessment of amount of gingival display, lip length (philtrum and vermilion length), and smile type.
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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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: EMG-guided 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. |
Procedure: Botox injection
Botox injection
Other Names:
Device: EMG
Quantitative Electromyography
Other Names:
Drug: Zinc Supplement
To increase efficacy of Botox
Other Names:
|
| Active Comparator: Conventional Botox injection in Yonsei point 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
Botox injection
Other Names:
Drug: Zinc Supplement
To increase efficacy of Botox
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- Quantitative EMG [Baseline, One-week and six-months follow-up]
Will be measured using EMG in mv.
- 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.
- Post-operative pain [Baseline, One-week, and One-month follow-up]
Will be measured using visual analogue scale (VAS) from 1 to 10.
- 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
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with excessive gingival display.
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Patients with esthetic concerns.
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Patients with mild to moderate VME (vertical maxillary excess).
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Normal clinical crown dimensions.
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Patients aged 18 to 50.
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Systemically healthy patients.
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Non-smokers.
Exclusion Criteria:
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Patients with severe VME (vertical maxillary excess).
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Pregnant and breastfeeding women.
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Patients with gingival inflammation and/or enlargement.
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Inflammation or infection at the site of injection.
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Patients with known allergy to any of the components of Botox (i.e., saline, human albumin, lactose and sodium succinate).
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Patients using anticholinesterase or other agents affecting neuromuscular transmission.
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Psychologically unstable patients or those who have unrealistic expectations and questionable motives.
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Patients with neuromuscular disorders (e.g., myasthenia gravis, Eaton-Lambert syndrome).
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Cairo University
Investigators
- Principal Investigator: Sherry Fayez Akhnokh, BSc, Cairo University
- Study Director: Noha Ghallab, PhD, Cairo University
- Study Chair: Nesma Shemais, PhD, Cairo University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SFAkhnokh