Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT06577285

The Effect Of Botox In Patients With Gummy Smile With And Without Zinc And Phytase Supplementation.

Led by Cairo University · Updated on 2024-09-23

36

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Participants with esthetic concern of excessive gingival display who meets the inclusion criteria, will be carried out including history taking, clinical examination and initial therapy. The initial therapy will consist of periodontal treatment (phase I therapy) including supragingival scaling, subgingival debridement if needed. The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques. Patients who have inadequate crown length and width ratio or short clinical crown will receive esthetic crown lengthening procedure to adjust gingival levels before being included in this study. Patients in the intervention group I will take zinc gluconate 50 mg 1 per day to increase zinc level with phytase supplement 176mg (800FTU) 2 tablets per day to give the maximum absorption of zinc, both supplements will be given for 4 days before botulinum toxin injections. Patients in the intervention group II will take zinc gluconate 50 mg 1 per day to increase zinc level, 4 days before botulinum toxin injections. Patients in the control group will receive the Botulinum toxin injections only Clinical photographs will be taken at baseline, 2 weeks, 1 month, 3 months postoperatively.

CONDITIONS

Official Title

The Effect Of Botox In Patients With Gummy Smile With And Without Zinc And Phytase Supplementation.

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with excessive gingival display greater than 3 mm and normal clinical crown dimensions
  • Adults aged 18 to 60 years
  • Non-smokers
  • Systemically healthy individuals
  • Patients with hypermobile lip and mild vertical maxillary excess
Not Eligible

You will not qualify if you...

  • Severe vertical maxillary excess
  • Pregnant or lactating females
  • Patients with inflamed gingiva or gingival enlargement
  • Inflammation or infection at the injection site
  • Known allergy to components of Botulinum toxin A or B
  • Use of anticholinesterase or agents affecting neuromuscular transmission
  • Psychologically unstable individuals or those with unrealistic expectations
  • Dependence on facial movements for livelihood (e.g., actors, singers)
  • Neuromuscular disorders such as myasthenia gravis or Eaton-Lambert syndrome

AI-Screening

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Trial Site Locations

Total: 1 location

1

Faculty of Dentistry Cairo University

Cairo, Egypt

Actively Recruiting

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Research Team

M

Mawda M Hussain, Bachelor

CONTACT

N

Nesma F Shemais, lecturer

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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