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

NCT03717987 | Completed Phase 3

• 1 other identifier: 130388
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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).

Conditions

Excessive Gingival Display

Keywords

gummy smile; Botulinum toxin type A; excessive gingival display

Outcome Measures

Primary Outcomes (1)

• Change in the amount of gingival display

  Change in gingival display will be measured using a ruler

  it will be measured after 2 weeks, then after 6, 12, 18 and 24 weeks

Study Arms (2)

Botulinum toxin A injection

ACTIVE COMPARATOR

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

Zinc supplementationj prior to Botulinum toxin A injection

ACTIVE COMPARATOR

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; Dietary Supplement: Zinc supplementation

Interventions

Botulinum toxin type A DRUG

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).

Botulinum toxin A injection; Zinc supplementationj prior to Botulinum toxin A injection

Zinc supplementation DIETARY_SUPPLEMENT

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

Zinc supplementationj prior to Botulinum toxin A injection

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, 11553, Egypt

Location

Related Publications (1)

• Shemais N, Elarab AE, ElNahass H. The effect of botulinum toxin A in patients with excessive gingival display with and without zinc supplementation: randomized clinical trial. Clin Oral Investig. 2021 Nov;25(11):6403-6417. doi: 10.1007/s00784-021-03944-2. Epub 2021 May 5.

  PMID: 33950373 BACKGROUND

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator at Faculty of Dentistry, Cairo University

Study Record Dates

• First Submitted: October 21, 2018
• First Posted: October 24, 2018
• Study Start: January 3, 2019
• Primary Completion: September 1, 2019
• Study Completion: December 12, 2019
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)