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Recruiting NCT06075134

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

No phase Interventional Excessive Gingival Display

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Botox injection, EMG, Zinc Supplement.
Who it may be relevant to
Registry conditions: Excessive Gingival Display. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

Interventions

  • Procedure Botox injection
    Botox injection
  • Device EMG
    Quantitative Electromyography
  • Drug Zinc Supplement
    To increase efficacy of Botox

Primary outcome measures

  • Change in amount of gingival display [Time frame: Baseline, One-week, One-month, three-months, and six-months follow-up]
Secondary outcome measures (6)
  • Quantitative EMG [Time frame: Baseline, One-week and six-months follow-up]
  • Patient satisfaction [Time frame: Baseline, One-week, One-month, three-months, and six-months follow-up]
  • Post-operative pain [Time frame: Baseline, One-week, and One-month follow-up]
  • Smile type [Time frame: Baseline, One-week, One-month, three-months, and six-months follow-up]
  • Change in lip length [Time frame: Baseline, One-week, One-month, three-months, and six-months follow-up]
  • Esthetics (Symmetry) for operators [Time frame: Baseline, One-week, One-month, three-months, and six-months follow-up]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Dentistry, Cairo University — Cairo

Identifiers

NCT: NCT06075134 · SFAkhnokh

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗