Comparative evaluation of conventional and 3D printed foldable rubber dam frame in children aged 6-12 years.-Randomized Clinical Trial.
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- to assess and compare Oxygen saturation
研究概览
简要总结
The study will be carried out on 20 children aged from 6 - 12 years of age. A written informed consent will be taken from parents.
This will be a randomized clinical trial with parallel design and allocation ratio of 1:1.
The recruited children will be randomized with single blind technique and lottery system will be used to assign patients two set of closed envelops will be made mentioning conventional rubber dam frame and 3d printed rubber dam frame in 10 envelops each. After being selected the same envelop will be discarded to provide exact allocation ratio. Groups will be divided into one of the following two groups.
D****ividing the samples into twogroups named as Group Aand B.
In Group A conventional rubber dam frame will be placed in the patients.
In Group B 3d printed foldable rubber dam frame will be placed in the patients.
A conventional rubber dam frame will be placed by punching the holes in the rubber dam sheet, followed by securing the sheet on the frame. Rubber dam sheet will be secured in the patient by placing clamps.
A modified rubber dam frame will be placed by punching the holes in the rubber dam sheet, followed by securing the sheet on the frame. Rubber dam sheet will be secured in the patient by placing clamps.
Oxygen saturation and cardiac frequency with the pulse oximeter will be assessed before and during the rubber dam placement. The statistical analysis will be carried out using SPSS software for Windows (SPSS Inc., Chicago, Ill., USA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children of both gender.
- •Dental patients ranging from 6 to 12 years requiring pit and fissure sealant and restorative procedures.
- •Children and parents who will provide their assent and consent respectively.
排除标准
- •Children with special healthcare needs ( Physically disabled and Mentally retarded patients ).
- •Children with mouth breathing habit.
- •Children with upper respiratory tract infection.
结局指标
主要结局
to assess and compare Oxygen saturation
时间窗: before and during the procedure
次要结局
- to assess and compare cardiac frequency(before and during the procedure)
研究者
Dr Hetvi Tanna
College of Dental Sciences, Amargadh, Bhavnagar, Gujarat.