CTRI/2019/05/018896尚未招募4 期
To compare the biofilm formation following the application of Chitosan varnish or Chlorhexidine varnish in patients undergoing fixed orthodontic treatment: A double blinded randomised controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Assessment of biofilm formation using Bonded Bracket Index (Plaque index) following the use of chitosan varnish or chlorhexidine varnish in patients undergoing fixed orthodontic therapy.
研究概览
简要总结
In this study we are assessing the biofilm formation following the application of a new Chitosan-based varnish in orthodontic patients. The clinical relevance of this trial is to study if inhibition of biofilm formation will render the tooth less prone to the development of white-spot lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 32.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients undergoing fixed orthodontic therapy in the age group of
- •Maxillary arch with permanent dentition.
- •Patients undergoing orthodontic treatment with fixed appliances with conventional metal brackets.
- •Patients with good oral hygiene and with no incipient carious lesion.
- •Patients providing informed consent
- •Patients under 18 years informed consent will be obtained from their parents.
排除标准
- •Patients with systemic diseases, fluorosis.
- •Patients on metal self-ligating or ceramic brackets.
- •Patients with periodontitis with probing depth > 4mm
- •Patients taking antibiotics 3 months prior to the study
- •Smokers, pregnant ladies.
- •Patient with cleft lip, cleft palate and other dento-facial abnormalities.
- •Other oral fixed appliances.
结局指标
主要结局
Assessment of biofilm formation using Bonded Bracket Index (Plaque index) following the use of chitosan varnish or chlorhexidine varnish in patients undergoing fixed orthodontic therapy.
时间窗: 0 Week (T0) | 1 Week (T1) | 2 Weeks (T2) | 3 Weeks (T3) | 4 Weeks (T4) | 5 Weeks (T5) | 6 Weeks (T6)
次要结局
- a. Quantitative assessment of S. mutans following the application of chitosan varnish or chlorhexidine varnish in patients undergoing fixed orthodontic therapy.(b. Estimation of plaque pH following the application of chitosan varnish or chlorhexidine varnish in patients undergoing fixed orthodontic therapy.)
研究者
研究点 (1)
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