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The Effect of Botulinum Toxin A In Patients With Excessive Gingival Display With And Without Zinc Supplementation

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ClinicalTrials.gov Identifier: NCT03717987
Recruitment Status : Not yet recruiting
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Nesma Mohamed Fouad Shemais, Cairo University

Brief 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).


Condition or disease Intervention/treatment Phase
Excessive Gingival Display Drug: Botulinum toxin type A Dietary Supplement: Zinc supplementation Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Botulinum Toxin A In Patients With Excessive Gingival Display With And Without Zinc Supplementation
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Active Comparator: Botulinum toxin A injection
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.
Drug: Botulinum toxin type A
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).

Active Comparator: Zinc supplementationj prior to Botulinum toxin A injection
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.
Drug: Botulinum toxin type A
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).

Dietary Supplement: Zinc supplementation
zinc supplementation will be given to patients in the intervention arm 4 days prior to Botulinum toxin type A injection




Primary Outcome Measures :
  1. Change in the amount of gingival display [ Time Frame: it will be measured after 2 weeks, then after 4, 8, 16, 20 and 24 weeks ]
    Change in gingival display will be measured using a ruler



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717987


Contacts
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Contact: Nesma M Shemais, MSc 01005615697 nesma.shemais@dentistry.cu.edu.eg
Contact: Hani M Elnahass, PhD nahass77@gmail.com

Locations
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Egypt
Faculty of Dentistry, Cairo University
Cairo, Egypt, 11553
Sponsors and Collaborators
Cairo University

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Responsible Party: Nesma Mohamed Fouad Shemais, Demonstrator at Faculty of Dentistry, Cairo University, Cairo University
ClinicalTrials.gov Identifier: NCT03717987    
Other Study ID Numbers: 130388
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nesma Mohamed Fouad Shemais, Cairo University:
gummy smile
Botulinum toxin type A
excessive gingival display
Additional relevant MeSH terms:
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Zinc
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Nutrients
Growth Substances
Neuromuscular Agents
Peripheral Nervous System Agents