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RecruitingNot ApplicableNCT06075134

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

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

Sponsor

Cairo University

Enrollment

32 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Excessive Gingival Display

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

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria7

  • 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 Criteria8

  • 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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Interventions

PROCEDUREBotox injection

Botox injection

DEVICEEMG

Quantitative Electromyography

DRUGZinc Supplement

To increase efficacy of Botox

Locations(1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

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NCT06075134

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