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

NCT06075134 | Recruiting

• 1 other identifier: SFAkhnokh
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Excessive Gingival Display

Outcome Measures

Primary Outcomes (1)

• Change in amount of gingival display

  Will be measured using ruler in mm.

  Baseline, One-week, One-month, three-months, and six-months follow-up

Secondary Outcomes (6)

• Quantitative EMG

  Baseline, One-week and six-months follow-up

• Patient satisfaction

  Baseline, One-week, One-month, three-months, and six-months follow-up

• Post-operative pain

  Baseline, One-week, and One-month follow-up

• Smile type

  Baseline, One-week, One-month, three-months, and six-months follow-up

• Change in lip length

  Baseline, One-week, One-month, three-months, and six-months follow-up

Study Arms (2)

EMG-guided Botox injection

EXPERIMENTAL

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; Device: EMG; Drug: Zinc Supplement

Conventional Botox injection in Yonsei point

ACTIVE COMPARATOR

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; Drug: Zinc Supplement

Interventions

Zinc Supplement DRUG

To increase efficacy of Botox

Also known as: Zinc supplement in the form of tablets

Conventional Botox injection in Yonsei point; EMG-guided Botox injection

Botox injection PROCEDURE

Botox injection

Also known as: Botulinum toxin injection

Conventional Botox injection in Yonsei point; EMG-guided Botox injection

EMG DEVICE

Quantitative Electromyography

Also known as: Electromyography

EMG-guided Botox injection

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Botulinum Toxins, Type A; Botulinum Toxins; Electromyography

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography

Study Officials

• Sherry Fayez Akhnokh, BSc

  Cairo University

  PRINCIPAL INVESTIGATOR

• Noha Ghallab, PhD

  Cairo University

  STUDY DIRECTOR

• Nesma Shemais, PhD

  Cairo University

  STUDY CHAIR

Central Study Contacts

Sherry Fayez Akhnokh, BSc

CONTACT

+0201284857175; sherry.akhnokh@dentistry.cu.edu.eg

Nesma Shemais, PhD

CONTACT

nesma.shemais@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Periodontology Resident

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 10, 2023
• Study Start: November 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

EG (1)