ASSESSMENT OF SALIVARY PH, FLOW RATE, BUFFERING CAPACITY AND ALPHA AMYLASE ENZYME ACTIVITY IN CARIES FREE AND CARIES ACTIVE CHILDREN IN EARLY CHILDHOOD CARIES – A RANDOMIZED CLINICAL TRIAL.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To determine the pH, Flowrate, Buffering capacity in the saliva of children with and without caries using pH meter. To estimate the salivary alpha amylase enzyme activity in the saliva of children with and without caries using DNS Reagent and UV spectrophotometer.
研究概览
简要总结
The present study will be done on 50 subjects to assess salivary pH, flow rate, buffering capacity and alpha amylase in children with caries and without caries aged 3-6 years. 25 subjects in each group, A thorough clinical examination will be done for active carious lesions using dmfs indices(>=4active caries). An unstimulated saliva sample is collected. The subjects will be asked to seat comfortably with eyes open, head tilted slightly forward with restricted orofacial movements, and will be instructed to rest for 5 min. Saliva will be allowed to accumulate in the floor of the mouth, and the subjects will be asked to spit into a sterile saliva collecting vial. All the samples will be transferred aseptically and sent for analysis to assess salivary pH, flowrate, buffering capacity and alpha amylase enzyme activity.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 3.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •1Children of 3-6 years of age.
- •2Children with 4 and more than 4 active carious lesions.
- •3Children with no caries.
- •4Parents giving consent for the study.
排除标准
- •1Children who received fluoride topical application during the last 1 month 2Children requiring special health care needs.
- •3Pulpally involved teeth.
- •4Children who were on antibiotic therapy within the past 3 months.
- •5Children with genetic diseases or syndromes.
- •6Children on any medications.
结局指标
主要结局
To determine the pH, Flowrate, Buffering capacity in the saliva of children with and without caries using pH meter. To estimate the salivary alpha amylase enzyme activity in the saliva of children with and without caries using DNS Reagent and UV spectrophotometer.
时间窗: Baseline
次要结局
未报告次要终点