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

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.

Study Overview

• Status: Recruiting
• Conditions: Excessive Gingival Display
• Intervention / Treatment: Dietary supplement: zinc gluconate 50 mg with phytase supplement 176mg (800FTU); Dietary supplement: zinc gluconate 50 mg

Detailed Description

Initial examination:

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.

Preoperative procedures:

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.

Clinical photographs:

Clinical photographs will be taken at baseline, 2 weeks, 1 month, 3 months postoperatively.

Intervention group I:

Patients in the intervention group I will take zinc gluconate 50 mg (Now food company) 1 per day to increase zinc level with phytase supplement 176mg (800FTU) (Goodphyte company) 2 tablets per day to give the maximum absorption of zinc, both supplements will be given for 4 days before botulinum toxin injections.

Intervention group II:

Patients in the intervention group II will take zinc gluconate 50 mg (Now food company) 1 per day to increase zinc level, 4 days before botulinum toxin injections.

Control group:

Patients in the control group will receive the Botulinum toxin injections only.

Botulinum toxin type A injection:

The patients will be injected at both sides into the "Yonsei point," (3Units) the point that would target 3 muscles responsible for upper lip elevation during smiling, including the levator labii superioris alaeque nasi (LLSAN), in a single injection. This landmark will be identified as the center of a triangle formed by the convergence of the LLSAN, the levator labii superioris (LLS), and the Zygomaticus minor 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).

Postoperative care:

After Botox injection the patients will be instructed to:

1. Remain upright for 4 hours after injection (patients may lie in a reclined position, but not lay flat)
2. Refrain from aerobic exercise that increases the heart rate.
3. Not to massage or manipulate injected areas for 24 hours after injections,
4. Refrain from using ibuprofen, for 24 hours following injection.
5. If bruising appears, apply ice to area for 15 minutes every hour to decrease bruising.

Follow up:

Botox will gradually take effect over 7-10 days with optimum result at 2 weeks. After 2 weeks the patients would come for an additional touch up dose (1 unit at each injection point)

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mawda M Hussain, Bachelor; Phone Number: +201501005110; Email: mawda.mohamed@dentistry.cu.edu.eg
• Study Contact Backup: Name: Nesma F Shemais, lecturer; Phone Number: +201005615697; Email: nesma.shemais@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Faculty of Dentistry Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Severe VME.
2. Pregnant or lactating females.
3. Patients with inflamed gingiva or gingival enlargement.
4. Inflammation or infection at the site of injection.
5. 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).
6. Patients using anticholinesterase or other agents interfering with neuromuscular transmission.
7. Psychologically unstable or who have questionable motives and unrealistic expectations.
8. Dependent on intact facial movements and expressions for their livelihood (e.g. actors, singers, musicians and other media personalities).
9. Afflicted with a neuromuscular disorder (e.g. myasthenia gravis, Eaton- Lambert syndrome).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention group I; Patients in the intervention group I will take zinc gluconate 50 mg (Now food company) 1 per day to increase zinc level with phytase supplement 176mg (800FTU) (Goodphyte company) 2 tablets per day to give the maximum absorption of zinc, both supplements will be given for 4 days before botulinum toxin injections.	Dietary supplement: zinc 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
Active Comparator: Intervention group II; Patients in the intervention group II will take zinc gluconate 50 mg (Now food company) 1 per day to increase zinc level, 4 days before botulinum toxin injections.	Dietary supplement: zinc gluconate 50 mg; zinc gluconate 50 mg 1 per day, 4 days before botulinum toxin injections.
No Intervention: Control group; Patients in the control group will receive the Botulinum toxin injections only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival display	To measure the amount of gingival display, a digital camera will be used to take the close up perioral as well as frontal smiling photographs. Care will be taken to capture a nonposed spontaneous smile. A measuring scale with ruler will be used for standardization of the photographs.	The gingival display will be measured at baseline, 2 weeks, 4 weeks, 2 months, 3 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrical activity of the smile muscles (EMG)	The compound muscle action potential is an electromyography investigation that measures the simultaneous action potentials for a group of muscle fibers in the same area	baseline, 2 weeks and 3 months
Smile type	Classification by (Rubin 1974) according to neuromuscular smile pattern Three main types: The commissure smile: Mona Lisa smile, where the corners of the mouth are pulled up and outward followed by the levators of the upper lips contracting to show the upper teeth. The cuspid (canine) smile: The levator labii superioris are dominant. They contract first, exposing the canine teeth. The corners of the mouth contract secondarily to pull the lips upward and outward. The complex smile: all the elevators of the lips, the elevators of the corners of the mouth, and the depressors of the lower lips contract at the same time to show all the upper and lower teeth	baseline, 2 weeks and 3 months:
Esthetics (Symmetry) for operators	A group of 12 dentists will evaluate the before and after photographic records and rate the results on a 1 to 5 point scale.	baseline, 2 weeks and 3 months:
Patient satisfaction (smile self-assessment)	Will be measured by using questionnaire using Likert scale; Very dissatisfied; Dissatisfied; Neutral; Satisfied; Very satisfied	2 weeks, 3 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Weam A El-Battawy, Ass. Prof., Cairo University; Principal Investigator: Mawda M Hussain, Bachelor, Cairo University; Study Chair: Nesma F Shemais, lecturer, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Botulinum Toxin A; Botox Injection; Excessive Gingival Display; Zinc And Phytase Supplementation; Gummy Smile
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Trace Elements; Micronutrients; Zinc
• Other Study ID Numbers: 18514PER3_3_1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No