EMG-guided Botox Injection Versus Conventional Botox Injection in Gummy Smile Patients
NCT ID: NCT06075134
Last Updated: 2023-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
32 participants
INTERVENTIONAL
2023-11-30
2024-08-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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EMG-guided Botox injection
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.
Botox injection
Botox injection
EMG
Quantitative Electromyography
Zinc Supplement
To increase efficacy of Botox
Conventional Botox injection in Yonsei point
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.
Botox injection
Botox injection
Zinc Supplement
To increase efficacy of Botox
Interventions
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Botox injection
Botox injection
EMG
Quantitative Electromyography
Zinc Supplement
To increase efficacy of Botox
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
50 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Sherry Fayez Akhnokh
Periodontology Resident
Principal Investigators
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Sherry Fayez Akhnokh, BSc
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Noha Ghallab, PhD
Role: STUDY_DIRECTOR
Cairo University
Nesma Shemais, PhD
Role: STUDY_CHAIR
Cairo University
Central Contacts
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Other Identifiers
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SFAkhnokh
Identifier Type: -
Identifier Source: org_study_id
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