The Effect Of Botulinum Toxin A In Patients With Excessive Gingival Display With And Without Zinc And Phytase Supplementation: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Cairo University
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Gingival display
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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).
Outcomes
Primary Outcomes
Gingival display
Time Frame: The gingival display will be measured at baseline, 2 weeks, 4 weeks, 2 months, 3 months.
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.
Secondary Outcomes
- Esthetics (Symmetry) for operators(baseline, 2 weeks and 3 months:)
- 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:)
Investigators
Mawda Mohamed Hussain Eltoum
Principle investigator Mawada Mohamed Master Degree Student, Periodontology department, Faculty of Dentistry, Cairo University
Cairo University