Assessment of retention ability of low-cost and high-cost glass ionomer cements as ART restorative material in deciduous molars: a randomized clinical trial
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- The high-cost GIC material presented a 2-fold more likely survival rate than the low-cost cement with similar cost-effectiveness.
研究概览
简要总结
Dental caries is an infectious disease that has afflicted the human race since ancient times. It is a multifactorial disease that results from interplay of principal factors: the host, the micro flora, and the diet or substrate. Globally, dental caries ranks among the most prevalent diseases of humans. It can start soon after primary teeth erupt in early childhood and continue throughout adulthood. It is a public health problem in most countries. The WHO Global Oral Data Bank indicates improvements in most industrialized nations and deterioration for most developing countries. Despite our ability to prevent this disease, dental caries is still alive and well, affecting large sections of the population. Hence there is a need to adopt various strategies to control dental caries globally.
A shift from the traditional approach of maximal intervention and invasiveness to the approach of minimal intervention and invasion, use of adhesive restorative materials has been a changing trend currently. One of these concepts is the Atraumatic Restorative Treatment (ART) which use glass ionomer cement to restore the cavities.
In countries like India, where the socio-economic status of majority of the population is low, there is less affordability to the dental services. Hence this study aims to check the retention ability of low-cost and high-cost glass ionomer cements as ART restorative material in deciduous molars and also checks for the cost-effectiveness of both the cements.
This was a double blind, randomized clinical trial conducted among 5-7 year old school children in Bangalore city. The informed consent was obtained from the parents of all the participants before the start of the study. Ninety-four school children who satisfied the inclusion and exclusion criteria were selected for the study. Split-mouth technique was used wherein all participants received restorations with two different GIC cements.
The restorations were assessed at the end of 3, 6 and 12 month intervals for the survival rate of both the cements as well as their cost-effectiveness. The results showed that the survival rate of high-cost cement was more than that of the low-cost cement at all the follow-up periods. Direct cost of both the restorations showed that the low cost cement was cost-effective than high cost with a difference of Rs.82.
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 and Investigator Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 7.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 5-7years who were willing to participate and whose parents gave consent for the operative procedures were included in the study.
- •Presence of at least two occlusal carious lesions present bilaterally or contra laterally in deciduous molars extending into the dentin.
- •The cavity entrance should be at least 1mm, which permits access for the smallest spoon excavator.
排除标准
- •Children aged 5-7 years with oral and maxillofacial disability, intraoral pathology, developmental anomalies.
- •Children aged 5-7 years with hypoplastic teeth and mobility.
- •Children aged 5-7 years with systemic illness and on regular medication.
- •Teeth with tender on percussion, pulpal exposure, history of pain, and presence of swelling or fistula.
- •Proximal surface caries as evidenced on clinical examination.
结局指标
主要结局
The high-cost GIC material presented a 2-fold more likely survival rate than the low-cost cement with similar cost-effectiveness.
时间窗: At the end of 3months, 6months and 12monnths
次要结局
- the survival rates of low cost cement were 87.2%, 81.7%, 67.3% and that of high cost cement were 96.8%, 95.8%, 91.9% at the end of 3months, 6months and 12months respectively. The direct cost of the ART restoration for low-cost cement was Rs. 301.4 per restoration and Rs. 383.7 per restoration for high-cost cement.(3months, 6months, 12months)