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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botox injection | Procedure | Botox injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative EMG | Will be measured using EMG in mv. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sherry Fayez Akhnokh, BSc | Contact | +0201284857175 | sherry.akhnokh@dentistry.cu.edu.eg | |
| Nesma Shemais, PhD | Contact | nesma.shemais@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Sherry Fayez Akhnokh, BSc | Cairo University | Principal Investigator |
| Noha Ghallab, PhD | Cairo University | Study Director |
| Nesma Shemais, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Cairo University | Recruiting | Cairo | Egypt |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D001905 | Botulinum Toxins |
| D004576 | Electromyography |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| EMG | Device | Quantitative Electromyography |
|
|
| Zinc Supplement | Drug | To increase efficacy of Botox |
|
|
| 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. | 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 | 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. | 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. | Baseline, One-week, One-month, three-months, and six-months follow-up |
| Cairo University |
| Study Chair |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D004568 | Electrodiagnosis |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009213 | Myography |