Comparative Efficacy of Botulinum Toxin Type A Injection Versus Placebo in the Correction of gummy Smile Between Khat Chewers and Non-Khat Chewers : A Randomized Clinical Trial
Phase 3
Completed
- Conditions
- Excessive gingival display ( gummy smile) measurment ( 3 - 8 mm ) due to hyperactive lip and short lip. measurment of the upper lip lenghand lip mobilitymeasurment of CEJCephalometric analysisGummy smile - Botox - Placebo - khat chewer - non khat chwere
- Registration Number
- TCTR20240719004
- Lead Sponsor
- Hospital of Stomatology of Sana a University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
yemeni patients
gummy smile due to short or hyperactive lip with excessive gingival display from 3-8 mm on smiling.
no systemic diseases
individual with khat chweing habits ( 3-5) years - ( 3 hours duration) frequency of 2-3
days a week.
Exclusion Criteria
pregnant or breastfeeding
smoker.
any allergies or dermal infectin.
any diseases or using any medications.
had previous Botos administration less than 4 months ago.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the effect of Botox in the treatment of gummy smile in khat chewers and non khat chewers 2 weeks ,one month, 2 months,3 months , 4months measuring the amount of improvement ( the improvement degree % ) by measued the gingival display from the lower border of the upper lip to the incisal edge before and after the njection
- Secondary Outcome Measures
Name Time Method trearment of gummy smile with placebo in khat chewers and non khat chewers. 2 weeks ,one month, 2 months,3 months , 4months measuring the amount of improvement ( the improvement degree % ) by measued the gingival display from the lower border of the upper lip to the incisal edge before and after the njection