A Clinical Trial to Assess the Retention and Caries Preventive Effect of Resin Based Sealants Versus ART Sealants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- retention rate as given by the simonsons criteria
研究概览
简要总结
Background and study aims:
The investigators are carrying out a clinical trial of two different sealant materials to compare the retentivity and decay inhibiting properties of the above said materials. it is a split mouth study, wherein the 2 sealant materials will be placed on the exactly opposite placed molars of 198 healthy school children in the age group between 6 - 12 yrs of age.
who can participate? school children in the age group between 6 - 12 yrs of age with non decayed contra lateral permanent 1st molars at a school in the southern part of India.
what does the study involve? over a period of 24 months, the retentivity and the decay preventing effects of these two sealant materials( RESIN BASED SEALANTS AND ART SEALANTS) will be clinically assessed by us.
possible benefits/ risks of participating in the trial the participants will be not be exposed to any kind of risks as it is a non invasive procedure the possible benefits may be preventing decay to the permanent molar in the long run
study start date/duration of the study? MARCH 2015 is the month wherein the sealant applications have started and expected to last till the April of 2017
funding? self funded study
详细描述
Pits and fissures in the first molars are the most susceptible sites for dental caries in the permanent dentition and contemporary studies show specifically that 85% or more of the caries is nested in the above-mentioned sites . Thus, prevention of caries in these tooth sites is of crucial importance in keeping a sound permanent dentition.
Sealing the pits and fissures of molars and premolars for prevention of dental caries was first introduced in the 1960s . It is now accepted as a highly effective method in preventing dental caries .
Prominently, there are basically two types of sealant materials..i.e resin based sealants which are flowable composite resins and Glass ionomer based sealants. Reading through the literature, it is well understood that the resin based sealants are more retentive than the GIC based sealants mainly because the enamel surface is etched prior to the placement and it is dispensed through syringes, thereby it generally adapts well to the surfaces. GIC sealants are known to be equally effective when to comes to caries prevention, but generally are far less retentive than the resin based sealants. the main issue regarding the placement of resin based sealants is that it is a cumbersome procedure requiring strict isolation. Looking at a dental public health point of view, especially in a country like India, the use of resin based sealants at outreach centres will be a problem because of the lack of adequate infrastructure.
To counter the limited applicability of resin based sealants in a field setting, the use of a high viscosity GIC sealant is advocated here. The high viscosity GIC sealant has a better compressive strength to take on the occlusal stress and thereby it is expected that the retention of the ART sealant (High viscous GIC sealant) using the ART technique (finger press technique) would be better than the conventional GIC based sealants. Till date, a very limited number of studies have been performed on the comparison between the ART sealant and the resin based sealant( gold standard) and thereby, this study has been conceived to assess the retentivity and the caries preventive effect of the above two systems.
The null hypothesis states that there is no expected difference between resin based sealants and ART sealants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children belonging to high caries risk group
- •1st permanent molars with an exaggerated pit and fissure system
排除标准
- •non cooperative children excluded
- •children with history of systemic diseases
- •parents haven't given their consent for this preventive therapy
结局指标
主要结局
retention rate as given by the simonsons criteria
时间窗: 24 months
次要结局
- caries incidence(24 months)
研究者
Dr. Praveen B.H
A randomized controlled clinical trial to assess the retention and caries preventive effect of Resin based sealant versus ART sealant among the 6-12 yr old school children of a district in India. A 24 months follow up study.
Kamineni Institute of Dental Sciences