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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240719004
Enrollment
60
Registered
2024-07-19
Start date
2024-01-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Excessive gingival display ( gummy smile) measurment ( 3 - 8 mm ) due to hyperactive lip and short lip. measurment of the upper lip lengh and lip mobility measurment of CEJ Cephalometric analysis Gummy smile - Botox - Placebo - khat chewer - non khat chwere

Interventions

a total of 60 individual having gummy smile , will be categorize into two groups: group 1 ( Test )
40 individual who have Botox injection in khat chewers and non khat chewers.,group 2 ( control)
20 individual who have placebo injection in khat chewer and non khat chewers
Experimental Drug,Experimental Drug
treatment of gummy smile with Botox in khat chewer patients,treatment gummy smile / placebo

Sponsors

Hospital of Stomatology of Sana a University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to 45 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Yemen

Contacts

Public ContactManal Abdullah

stomatology hospital of sanaa university

Manal.Abdullah776699@gmail.com00967776643443

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026