The Effect Of Botox In Patients With Gummy Smile With And Without Zinc And Phytase Supplementation.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: zinc gluconate 50 mg with phytase supplement 176mg (800FTU), zinc gluconate 50 mg.
- Who it may be relevant to
- Registry conditions: Excessive Gingival Display. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect Of Botulinum Toxin A In Patients With Excessive Gingival Display With And Without Zinc And Phytase Supplementation: A Randomized Clinical Trial
Overview
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.
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)
Interventions
- 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 - Dietary supplement zinc gluconate 50 mg
zinc gluconate 50 mg 1 per day, 4 days before botulinum toxin injections.
Primary outcome measures
- Gingival display [Time frame: The gingival display will be measured at baseline, 2 weeks, 4 weeks, 2 months, 3 months.]
Secondary outcome measures (4)
- Patient satisfaction (smile self-assessment) [Time frame: 2 weeks, 3 months]
- Electrical activity of the smile muscles (EMG) [Time frame: baseline, 2 weeks and 3 months]
- Smile type [Time frame: baseline, 2 weeks and 3 months:]
- Esthetics (Symmetry) for operators [Time frame: baseline, 2 weeks and 3 months:]
Eligibility criteria
Inclusion criteria
- Patients with excessive gingival display >3mm and with normal clinical crown dimensions.
- Adults >18 years.
- Non-smokers.
- Systemically healthy.
- Hypermobile lip and 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Dentistry Cairo University — Cairo
Identifiers
NCT: NCT06577285 · 18514PER3_3_1