Botox treatment for gummy smile with zinc and phytase supplements
The Effect Of Botulinum Toxin A In Patients With Excessive Gingival Display With And Without Zinc And Phytase Supplementation: A Randomized Clinical Trial
NA · Cairo University · NCT06577285
This study is testing if adding zinc and phytase supplements before Botox injections can help people with a gummy smile look better after treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Cairo University (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06577285 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of botulinum toxin A injections in patients with excessive gingival display, commonly known as a gummy smile. Participants will undergo initial periodontal therapy and may receive esthetic crown lengthening if necessary. The intervention groups will include patients taking zinc gluconate with and without phytase supplements prior to receiving Botox injections, while a control group will receive only the injections. Clinical photographs will be taken at various intervals to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with excessive gingival display greater than 3mm and normal clinical crown dimensions.
Not a fit: Patients with severe vertical maxillary excess, pregnant or lactating females, or those with certain systemic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the aesthetic appearance of patients with gummy smiles.
How similar studies have performed: While the use of botulinum toxin for aesthetic purposes is well-documented, the specific combination of zinc and phytase supplementation in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with excessive gingival display \>3mm and with normal clinical crown dimensions. 2. Adults \>18 years. 3. Non-smokers. 4. Systemically healthy. 5. Hypermobile lip and mild VME. Exclusion Criteria: 1. Severe VME. 2. Pregnant or lactating females. 3. Patients with inflamed gingiva or gingival enlargement. 4. Inflammation or infection at the site of injection. 5. Patients with known allergy to any of the components of BTX-A or BTX-B (i.e. BTX, human albumin, saline, lactose and sodium succinate). 6. Patients using anticholinesterase or other agents interfering with neuromuscular transmission. 7. Psychologically unstable or who have questionable motives and unrealistic expectations. 8. Dependent on intact facial movements and expressions for their livelihood (e.g. actors, singers, musicians and other media personalities). 9. Afflicted with a neuromuscular disorder (e.g. myasthenia gravis, Eaton- Lambert syndrome).
Where this trial is running
Cairo
- Faculty of Dentistry Cairo University — Cairo, Egypt (RECRUITING)
Study contacts
- Principal investigator: Mawda M Hussain, Bachelor — Cairo University
- Study coordinator: Mawda M Hussain, Bachelor
- Email: mawda.mohamed@dentistry.cu.edu.eg
- Phone: +201501005110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Excessive Gingival Display, Botulinum Toxin A, Zinc And Phytase Supplementation, Botox Injection, Gummy Smile