Study of Papacarie® for Caries Removal.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 488
- 试验地点
- 2
- 主要终点
- Number of Participants With Treatment Failure
研究概览
简要总结
The purpose study are to evaluate the efficacy of Papacarie® for caries removal in comparison to the conventional drilling method.
详细描述
Dental caries in children continues to affect a significant portion of the world population, especially in developing countries. There are many techniques used for dental caries treatment. The conventional method is to remove caries and prepare the cavity using dental burs. Disadvantages of this method; however, include the patients' repulsion of drilling, and possible thermal changes on tooth surface that may have an effect on the dental pulp tissues. In addition, the drilling technique frequently requires local anesthesia injections and sometimes results in the removal of sound tooth tissues. To overcome these problems and preserve the healthy dental tissues, the chemo-mechanical caries removal method was developed. The advantage by chemomechanical caries removal include less traumatic, less need local anesthesia, reduced chance of dental pulp exposure. And also it could be benefit to medical compromised patients.
Papacarie® is a new chemo-mechanical technique for caries removal with few published research and case reports. A randomized controlled trial is therefore needed to determine the efficacy of its use in general population. The aims of this study are to evaluate the efficacy of a chemo-mechanical system (Papacarie®) for caries removal in comparison to the conventional drilling method.
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 (Investigator)
入排标准
- 年龄范围
- 7 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient inclusion criteria:
- •Child is between 7-8 years of ages (at date of enrollment) with at least one active caries lesion in second primary molar tooth with distinct dentine involvement requiring restoration
- •Child is in good general health and has no existing health condition that may interfere with treatment such as asthma, tuberculosis, rheumatic fever/ congenital heart diseases, jaundice, juvenile diabetes, haemophilia, thalassemia, leukemia, anemia , HIV , allergy to any drug, and epilepsy.
- •Tooth inclusion criteria:
- •Second primary molar tooth with one active caries lesion with distinct dentine involvement requiring restoration using the World Health Organization Criteria.
- •Tooth with isolated occlusal caries and caries extended on further than two-third of the dentine layer, which can be restoration as a Class I restoration.
- •Carious cavity must be large enough so that the hand instruments can be operated.
- •Tooth is vital without pathological process assessed clinically and radiographically.
排除标准
- •Patient exclusion criteria:
- •Child whose parent does not give informed consent.
- •Child who are unwilling to undergo the dental treatment.
- •Child who has a known allergy to the ingredients contained in dental anesthesia, Papacarie® or glass-ionomer filling material.
- •Tooth exclusion criteria:
- •Having extensive dental caries which may require pulp treatment.
- •Tooth with a pathological process of the dental tissue other than caries that could affect the treatment, such as tooth development disorders or adjacent soft tissue lesion.
结局指标
主要结局
Number of Participants With Treatment Failure
时间窗: two years
The dental restorations were evaluated at 6, 12, 18 and 24 months after treatment. Evaluation criteria included the condition of the filling material and presence of secondary caries at the margin of the restorations. The restoration status was re-categorized as a binary outcome: Treatment failure (Yes/No).
次要结局
- Number of Participants With Complete Caries Removal(immediately after treatment)
- Levels of Pain and Discomfort(immediately after treatment)
- Time Use for Caries Removal(Immediately while treatment)
- Incidence of Secondary Caries(two years)
研究者
Kemporn Kitsahawong
Associated Professor
Khon Kaen University