Assessment of oral hygiene status and evaluation of 25(OH)D and RANKL levels in saliva of children with Nephrotic syndrome and healthy children: A cross-sectional study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. To determine the oral hygiene status of Nephrotic syndrome children and healthy children.
研究概览
简要总结
A total of sixty children fulfilling the inclusion criteria will be selected. Thirty Nephrotic syndrome children will form the study group and thirty age matched healthy children will form the control group. Oral examination for Nephrotic syndrome children will be done at Sri Sai Kanva Hospital under natural daylight using a sterilized mouth mirror and CPITN probe (Community Periodontal Index for Treatment Needs). Oral examination for healthy children will be done at Department of Pediatric and Preventive Dentistry. Dental caries, plaque and gingival status will be assessed according to WHO criteria.
On completion of oral examination saliva samples will be collected in the morning from 09.00am to 11.00am and the children will be asked to avoid eating or drinking 1 hour before the collection of saliva samples. Unstimulated saliva samples will be collected using the spitting method. The subject is asked to sit comfortably for five minutes, then is asked to swallow the saliva in their oral cavity once, so measuring can commence. After that, their head is lowered and moved as little as possible (talking is restricted). During the measurement process the subject is not allowed to swallow. The saliva in their oral cavity is collected with lips closed and eyes open for one minute, then spitting will commence into a sterile container for five minutes. Saliva sample is transferred to eppendorf tube and stored in temperature controlled icebox. Within two hours of saliva sample collection, samples will be transferred to biochemistry laboratory for the assessment of 25(OH)D and RANKL levels in saliva by using enzyme- linked immune sorbent assay (ELISA). The centrifugation of 2500rpm is carried out for 10 minutes, and the specimen is immediately stored at –20 oC. The samples are stored in lab at -80 oC for extended storage. The obtained results will be subjected to statistical analysis.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 6.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with Nephrotic Syndrome.
- •Age range of 6 to 14 years children under corticosteroids.
- •Children not on other medication unrelated to Nephrotic Syndrome.
- •Parent’s/ Patient’s consent for study.
排除标准
- •Children with diseases other than Nephrotic Syndrome & taking medications for the same.
- •Children with other significant chronic disease.
- •Children who have undergone major surgery.
结局指标
主要结局
1. To determine the oral hygiene status of Nephrotic syndrome children and healthy children.
时间窗: one and half year
次要结局
- 2. To determine and compare 25(OH)D and RANKL levels in saliva of Nephrotic syndrome children and healthy children.(one and half year)
研究者
DR SPURTHY JAVALAKAR
The Oxford Dental College Bangalore