RecruitingNot ApplicableNCT06577285

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

The Effect Of Botulinum Toxin A In Patients With Excessive Gingival Display With And Without Zinc And Phytase Supplementation: A Randomized Clinical Trial


Sponsor

Cairo University

Enrollment

36 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria5

  • Patients with excessive gingival display \>3mm and with normal clinical crown dimensions.
  • Adults \>18 years.
  • Non-smokers.
  • Systemically healthy.
  • Hypermobile lip and mild VME.

Exclusion Criteria9

  • Severe VME.
  • Pregnant or lactating females.
  • Patients with inflamed gingiva or gingival enlargement.
  • Inflammation or infection at the site of injection.
  • 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).
  • Patients using anticholinesterase or other agents interfering with neuromuscular transmission.
  • Psychologically unstable or who have questionable motives and unrealistic expectations.
  • Dependent on intact facial movements and expressions for their livelihood (e.g. actors, singers, musicians and other media personalities).
  • Afflicted with a neuromuscular disorder (e.g. myasthenia gravis, Eaton- Lambert syndrome).

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Interventions

DIETARY_SUPPLEMENTzinc gluconate 50 mg with phytase supplement 176mg (800FTU)

zinc gluconate 50 mg1 per day with phytase supplement 176mg (800FTU) (Goodphyte company) 2 tablets per day

DIETARY_SUPPLEMENTzinc gluconate 50 mg

zinc gluconate 50 mg 1 per day, 4 days before botulinum toxin injections.


Locations(1)

Faculty of Dentistry Cairo University

Cairo, Egypt

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NCT06577285


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