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

Excessive Gingival Display Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06075134
• Other study ID #: SFAkhnokh
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: August 2024

Study information

• Verified date: October 2023
• Source: Cairo University
• Contact: Sherry Fayez Akhnokh, BSc
• Phone: +0201284857175
• Email: sherry.akhnokh[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Excessive Gingival Display

Intervention

Procedure:
• Botox injection
Botox injection

Device:
• EMG
Quantitative Electromyography

Drug:
• Zinc Supplement
To increase efficacy of Botox

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

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