EMG-guided Botox Injection Versus Conventional Botox Injection in Gummy Smile Patients (NCT06075134) | Clinical Trial Compass
RecruitingNot Applicable
EMG-guided Botox Injection Versus Conventional Botox Injection in Gummy Smile Patients
Egypt32 participantsStarted 2024-11-01
Plain-language 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).
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in amount of gingival display
Timeframe: Baseline, One-week, One-month, three-months, and six-months follow-up