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

Cairo University32 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Excessive Gingival Display

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Change in amount of gingival display

Will be measured using ruler in mm.

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

Secondary Outcomes

Quantitative EMG

Will be measured using EMG in mv.

Time frame: Baseline, One-week and six-months follow-up

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.

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

Post-operative pain

Will be measured using visual analogue scale (VAS) from 1 to 10.

Time frame: Baseline, One-week, and One-month follow-up

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

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

Change in lip length

Will be measured using UNC (University of North Carolina) -15 periodontal probe in mm.

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

Esthetics (Symmetry) for operators

Will be measured using 5-point Likert scale, where 1 is significantly asymmetrical and 5 is completely symmetrical.

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

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts