The Effect of Botulinum Toxin A In Patients With Excessive Gingival Display With And Without Zinc Supplementation
Condition: Excessive Gingival Display
Study type: Interventional
Phase: Phase 3

Summary: 
      It has been noted since the start of using botulinum toxin for both medical and cosmetic
      indications that some patients simply don't achieve the responses to the drug that others do,
      leading to increased dose requirements and more frequent treatments. It was from this
      observation that researchers started to look at the zinc levels of patients and consider the
      concept of supplementation. In a recent systematic review, it was reported that there is very
      scant evidence to determine the exact clinical effects and duration of BTX-A when injected to
      treat gummy smile patients. Therefore, the investigators want to administrate of zinc
      supplements to patients prior to BTX-A injection to study if it will enhance its clinical
      effects, since it is from the zinc dependent metalloprotease family, where for each botulinum
      toxin molecule to be effective in paralyzing a muscle response it must be associated with a
      molecule of zinc which could be found within the cells of the body.

      Participants with esthetic concern of excessive gingival display who meets the inclusion
      criteria will be assigned randomly and blindly to one of the 2 groups. Patients in the
      intervention group will take zinc supplement tablets to increase zinc levels for 4 days
      before botulinum toxin injections. While patients in the control group will take placebo
      tablets 4 days prior to the injections. All tablets will be placed in envelopes for blinding
      the operator, and numbered by a supervisor to allocate patients again in their groups for
      statistical results. Botulinum toxin type A will be injected in all patients at both sides
      into the "Yonsei point," (3Units) the point that would target 3 muscles responsible for upper
      lip elevation during smiling, including the LLSAN, in a single injection. This landmark was
      identified as the center of a triangle formed by the convergence of the LLSAN, the LLS, and
      the Zminor muscles and is located 1 cm lateral to the ala horizontally and 3 cm above the lip
      line vertically in both men and women. After 2 weeks the patients would come for an
      additional touch up dose (1 unit at each injection point).
    


Intervention name(s): Botulinum toxin type A; Zinc supplementation
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Botulinum toxin type A will be injected in all patients at both sides into the "Yonsei point," (3Units) the point that would target 3 muscles responsible for upper lip elevation during smiling, including the LLSAN, in a single injection. This landmark was identified as the center of a triangle formed by the convergence of the LLSAN, the LLS, and the Zminor muscles and is located 1 cm lateral to the ala horizontally and 3 cm above the lip line vertically in both men and women (Hwang et al. 2009) and (Nasr et al. 2015).; zinc supplementation will be given to patients in the intervention arm 4 days prior to Botulinum toxin type A injection
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: gummy smile; Botulinum toxin type A; excessive gingival display