Assessment of Inhibition of Biofilm Formation and Plaque Bacterial Count of Fluoride Varnish Containing Chlorhexidine and Cetylpyridinium Chloride Versus Conventional Fluoride Varnish Among High Caries Risk Patients: Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Plaque Retention
研究概览
简要总结
Two different Fluoride varnish systems(Fluoride varnish containing Chlorhexidine and Cetylpyridinium Chloride (CPC) and conventional fluoride) will be applied to high caries risk patients to assess their clinical effects on plaque accumulation and plaque bacterial count .
详细描述
Preoperative steps:
- The diagnostic chart will be filled including all data about the patient's medical history, dental history, plaque assessment and plaque bacterial count.
- Scaling and polishing will be carried out for subjects.
clinical steps:
- Control Group: Conventional Fluoride varnish (Fluor Protector, Ivoclar Vivadent - Schaan Liechtenstein) will be applied on dry teeth in a thin layer, allowed to dry for 1 minute, and participants will be instructed to avoid rinsing after application, only spitting. Eating, drinking and brushing should be avoided for 1 hour after varnish application.
- Intervention Group: Varnish containing Fluoride, Chlorhexidine and Cetylpyridinium Chloride (Cervitec F, Ivoclar Vivadent - Schaan Liechtenstein) will be applied on dry teeth in a thin layer, allowed to dry for 1 minute, and participants will be instructed to avoid rinsing after application, only spitting. Eating, drinking and brushing should be avoided for 1 hour after varnish application.
Each participant will be assessed for plaque retention using plaque index and Standardized photography and image analysis to disclosed dental plaque, and plaque bacterial count using culture media sensitive for mutans streptococci (MS) in the following intervals:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with good general state of health.
- •No signs of periodontitis.
- •Patients had a recorded high bacterial count after caries risk assessment.
- •No antibiotic treatment within 1 month prior to the start of the trial.
- •No current medication with anti-inflammatory drugs.
- •No use of antiseptic mouth rinses.
- •Non-smokers.
排除标准
- •Patients with disabilities, systemic disease or severe medical conditions.
- •Patients with severe or active periodontal disease.
- •Antibiotic treatment within 1 month prior to the start of the trial.
- •Current medication with anti-inflammatory drugs.
研究组 & 干预措施
intervention group
Varnish containing Fluoride, Chlorhexidine and Cetylpyridinium Chloride (Cervitec F, Ivoclar Vivadent - Schaan Liechtenstein) will applied to this group once at the beginning of the study.Plaque and bacterial count will be evaluated at intervals 2 weeks,4 weeks,12 weeks, and 24 weeks.
干预措施: Cervitec F, Ivoclar Vivadent - Schaan Liechtenstein (Drug)
control group
Varnish containing Fluoride (Fluor Protector, Ivoclar Vivadent - Schaan Liechtenstein). will applied to this group once at the beginning of the study.
Plaque and bacterial count will be evaluated at intervals 2 weeks,4 weeks,12 weeks, and 24 weeks.
干预措施: Fluor Protector, Ivoclar Vivadent - Schaan Liechtenstein (Drug)
结局指标
主要结局
Plaque Retention
时间窗: Patient will be evaluated at 24th week of the study in the morning before teeth brushing.
Checked using a disclosing agent by Silness and Löe Dental Plaque index
次要结局
未报告次要终点
研究者
Hadeer Hesham Mohamed
Principle Investigator
Cairo University