The Effect Of Botulinum Toxin A In Patients With Excessive Gingival Display With And Without Zinc And Phytase Supplementation: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Gingival display
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with excessive gingival display >3mm and with normal clinical crown dimensions.
- •Adults >18 years.
- •Non-smokers.
- •Systemically healthy.
- •Hypermobile lip and mild VME.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: zinc gluconate 50 mg (Dietary Supplement)
Control group
Patients in the control group will receive the Botulinum toxin injections only.
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.
干预措施: zinc gluconate 50 mg with phytase supplement 176mg (800FTU) (Dietary Supplement)
结局指标
主要结局
Gingival display
时间窗: 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.
次要结局
- 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:)
研究者
Mawda Mohamed Hussain Eltoum
Principle investigator Mawada Mohamed Master Degree Student, Periodontology department, Faculty of Dentistry, Cairo University
Cairo University