Effect of Fixed and Removable Space Maintainer on Some Salivary Parameters: An In-Vivo Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assessment of Salivary pH
研究概览
简要总结
The aim of this study is to evaluate and compare the effect of lower lingual holding arch space maintainer versus removable partial denture space maintainer on some salivary parameters (salivary flow rate, pH, viscosity and buffering capacity).
详细描述
This study is a randomized clinical trial, it will be conducted on forty children, aged from (7-10) years, who are in need for space maintainer.
- Children will be randomly and equally divided into two groups according to type of space maintainer used; group (1): twenty children with lower lingual holding arch, group (2): twenty children with removable partial denture.
- Un-stimulated and stimulated saliva will be collected at specific duration of time from children before the delivery of the appliance and after 1, 3 and 6 months of wearing the space maintainer to measure salivary flow rate, pH, viscosity and buffering capacity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 7 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy with no systemic disease. Age between 7-10 years old. Both boys and girls will be included.
- •Children with the following dental criteria:
- •Clinical criteria:
- •Children should have a good oral hygiene.
- •Children in mixed dentition stage.
- •Fully erupted permanent lower first molar.
- •Children with multiple loss of deciduous molar teeth.
- •Seek for space maintainer appliance.
- •Radiographic criteria :
- •Presence of at least 1mm bone overlaying successor.
- •Tooth germ with less than one third of the root formed.
排除标准
- •Allergy to any used material
研究组 & 干预措施
children with lower lingual holding arch space maintainer
non functional fixed space maintainer used in the mandibular arch to maintain arch length by prevention of mesial movement of permanent first molar
干预措施: lower lingual holding arch space maintainer (Device)
children with removable partial denture space maintainer
functional Removable space maintainer that not only maintain the mesiodistal space, but vertical dimension and masticatory function is also assured
干预措施: Removable partial denture space maintainer (Device)
结局指标
主要结局
Assessment of Salivary pH
时间窗: before delivery of appliance, after 1 month, 3 months, 6 months
Salivary pH will be measured using an electronic pH meter
Assessment of viscosity of saliva
时间窗: before delivery of appliance, after 1 month, 3 months, 6 months
Salivary viscosity will be determined by allowing saliva to flow through a tube of circular cross section to measure the flow rate . This will be done using the Ostwald viscometer.
Assessment of salivary flow of stimulated saliva
时间窗: before delivery of appliance, after 1 month, 3 months, 6 months
To stimulate saliva, the subjects will be asked to chew a piece of paraffin wax, and saliva will be collected for 5 min in a measuring cup with 1ml gradation marks; the stimulated salivary flow rate (ml/min) will be calculated by dividing the amount of expectorated saliva by 5 min
Assessment of salivary flow of un-stimulated saliva
时间窗: before delivery of appliance, after 1 month, 3 months, 6 months
Un-stimulated whole saliva will be collected from all individuals by direct expectoration into a sterile container over a period of 10 min by spitting method, so that the flow rate could be calculated by dividing the amount of expectorated saliva by 10 min
Assessment of buffering capacity
时间窗: before delivery of appliance, after 1 month, 3 months, 6 months
By estimating the pH change after HCl titration into un-stimulated saliva for a buffering capacity test.
次要结局
未报告次要终点