Excessive Gingival Display
Conditions
Brief 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).
Interventions
PROCEDUREBotox injection
Botox injection
DEVICEEMG
Quantitative Electromyography
DRUGZinc Supplement
To increase efficacy of Botox
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in amount of gingival display | Baseline, One-week, One-month, three-months, and six-months follow-up | Will be measured using ruler in mm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative EMG | Baseline, One-week and six-months follow-up | Will be measured using EMG in mv. |
| Patient satisfaction | Baseline, One-week, One-month, three-months, and six-months follow-up | Will be assessed using questionnaire, on a scale from 1 to 5, where 1 is completely not satisfied and 5 is completely satisfied. |
| Post-operative pain | Baseline, One-week, and One-month follow-up | Will be measured using visual analogue scale (VAS) from 1 to 10. |
| Smile type | Baseline, One-week, One-month, three-months, and six-months follow-up | Qualitative, by Rubin (1974). Smile is classified into 1. Corner of the mouth (Mona Lisa) smile, 2. Canine Smile, and 3. Full denture smile |
| Change in lip length | Baseline, One-week, One-month, three-months, and six-months follow-up | Will be measured using UNC (University of North Carolina) -15 periodontal probe in mm. |
| Esthetics (Symmetry) for operators | Baseline, One-week, One-month, three-months, and six-months follow-up | Will be measured using 5-point Likert scale, where 1 is significantly asymmetrical and 5 is completely symmetrical. |
Countries
Egypt
Contacts
CONTACTSherry Fayez Akhnokh, BSc
CONTACTNesma Shemais, PhD
PRINCIPAL_INVESTIGATORSherry Fayez Akhnokh, BSc
Cairo University
STUDY_DIRECTORNoha Ghallab, PhD
Cairo University
STUDY_CHAIRNesma Shemais, PhD
Cairo University
Outcome results
None listed