The Effect of Botulinum Toxin A In Patients With Excessive Gingival Display With And Without Zinc Supplementation
Status:
Unknown status
Trial end date:
2021-10-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 3
Details
Lead Sponsor:
Cairo University
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A onabotulinumtoxinA Zinc