The Effect Of Botox In Patients With Gummy Smile With And Without Zinc And Phytase Supplementation.

NCT06577285 | Recruiting DMC

• 1 other identifier: 18514PER3_3_1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Excessive Gingival Display

Keywords

Botulinum Toxin A; Excessive Gingival Display; Zinc And Phytase Supplementation; Botox Injection; Gummy Smile

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patient satisfaction (smile self-assessment)

  2 weeks, 3 months

• Electrical activity of the smile muscles (EMG)

  baseline, 2 weeks and 3 months

• Smile type

  baseline, 2 weeks and 3 months:

• Esthetics (Symmetry) for operators

  baseline, 2 weeks and 3 months:

Study Arms (3)

Intervention group I

ACTIVE COMPARATOR

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)

Intervention group II

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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

Interventions

zinc gluconate 50 mg with phytase supplement 176mg (800FTU) DIETARY_SUPPLEMENT

zinc gluconate 50 mg1 per day with phytase supplement 176mg (800FTU) (Goodphyte company) 2 tablets per day

Intervention group I

zinc gluconate 50 mg DIETARY_SUPPLEMENT

zinc gluconate 50 mg 1 per day, 4 days before botulinum toxin injections.

Intervention group II

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with excessive gingival display \>3mm and with normal clinical crown dimensions.
• Adults \>18 years.
• Non-smokers.
• Systemically healthy.
• Hypermobile lip and 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, Egypt

RECRUITING

MeSH Terms

Interventions

gluconic acid

Study Officials

• Weam A El-Battawy, Ass. Prof.

  Cairo University

  STUDY DIRECTOR

• Mawda M Hussain, Bachelor

  Cairo University

  PRINCIPAL INVESTIGATOR

• Nesma F Shemais, lecturer

  Cairo University

  STUDY CHAIR

Central Study Contacts

Mawda M Hussain, Bachelor

CONTACT

+201501005110; mawda.mohamed@dentistry.cu.edu.eg

Nesma F Shemais, lecturer

CONTACT

+201005615697; nesma.shemais@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator Mawada Mohamed Master Degree Student, Periodontology department, Faculty of Dentistry, Cairo University

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

EG (1)