The Effect Of Botox In Patients With Gummy Smile With And Without Zinc And Phytase Supplementation.
NCT Number: NCT06577285
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Excessive Gingival Display
Interventions: DIETARY_SUPPLEMENT: zinc gluconate 50 mg with phytase supplement 176mg (800FTU)|DIETARY_SUPPLEMENT: zinc gluconate 50 mg
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2025-06-01
Locations: Faculty of Dentistry Cairo University, Cairo, Egypt

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.

Primary Outcome Measures: 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: Patient satisfaction (smile self-assessment), Will be measured by using questionnaire using Likert scale, 2 weeks, 3 months|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: