Partial Excavation of Dentin Carious Lesions in Primary Molars: A Practice-Based Research Network (PBRN) Study
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Success
研究概览
简要总结
Background: The traditional approach of carious lesions with risk for progression has has been to excavate all infected and demineralised tissue before placement of the restoration. In primary teeth, treatment of deep carious lesions is associated with significant risk of pulp lesions and postoperative complications and thus the risk of the teeth being lost. During the past decade, more focus has been on biological methods for caries excavating of deep dentin lesions. An overview comparing different biological methods such as partial or stepwise excavation of deep dentin caries in primary teeth shows that they work as well as traditional methods performing complete caries excavation but have the benefits of reducing the risk of iatrogenic pulp damage [1-3].
Our primary hypothesis is that there is no difference in tooth or filling survival after partial caries excavation compared to complete caries excavation in primary molars.
The secondary hypothesis is that the therapist's knowledge, experience and treatment attitudes and choices are not affected by a participation in the study.
详细描述
The treatment of carious lesions with risk for progression has traditionally been done with caries removal and restorative treatment of the affected teeth. In primary teeth, different treatments for deep carious lesions have been described. Complete excavation aims to removing all infected and demineralised dentin with a high risk of pulpal exposure, postoperative complications and thus the risk of the teeth being lost. In many cases, treatment also involves pain and suffering for the patient, which can lead to dental fear among children.
In latest years there has been a growing evidence for the possibility of controlling the cariogenic biofilm in the lesion by isolating the infected tissue from the oral cavity with an isolating restoration and leaving infected tissue under the permanent restoration. The methods are considered to be able to slow down or arrest the caries progression in primary teeth so that the teeth exfoliate without causing pain or infection. When carious tissue is isolated from the oral environment deprives the residual bacteria from carbohydrates and has thus been shown to have an antibacterial effect and to stop further progression of the lesion [4-5]. Partial, i.e. one-step incomplete or selective excavation is one biological method that seals carious dentin under a definitive restoration, omitting any re-entry. This can thus be a treatment choice for the primary teeth.
An overview comparing different biological methods for caries excavation of deep dentin caries in primary teeth, such as partial or stepwise excavation shows that they work as well as traditional methods performing complete caries excavation but have the benefits of reducing the risk of iatrogenic pulp damage [1-4]. However, partial excavation compared with complete excavation in deep carious lesions in primary teeth has not previously been tested under practice-like conditions. If the study shows that the treatment is effective in clinical practice and in the hands of multiple operators, it will change the routine treatment of dentin caries in primary teeth, thus increasing the survival of teeth and fillings, as well as reducing the risk of unwanted injury to the pulp and pain and discomfort to the children.
Objectives and Hypothesis: The primary purpose of the study is to investigate the sustainability of filling and the tooth survival after two different methods of excavation of dentin caries in primary molars.
The primary hypothesis is that there is no difference in tooth or filling survival after partial caries excavation compared to complete caries excavation in primary molars.
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
- None
入排标准
- 年龄范围
- 3 Years 至 8 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children in the age of 3-8 years, with one or more primary molar teeth in a need of a restoration due to a moderate depth of carious lesion;
- •caries lesion diagnosed into dentin on radiographs though not exceeding the inner third of the dentin
- •caries lesion diagnosed visually with a cavity into dentin.
排除标准
- •Children with behaviour management problems.
- •Teeth with pulpal symptoms
- •Teeth expected to exfoliate within the next 18 months
结局指标
主要结局
Success
时间窗: 24 months
Success will be measured by assessing if the restoration is in place (i.e. tooth in place vs. tooth lost) and without comment.
Tooth survival
时间窗: 24 months
Tooth survival will be measured by assessing tooth exfoliation without causing pain or infection.
次要结局
- Decision-making Questionnaire(24 months)
研究者
Annika Julihn
DDS, PhD
Karolinska Institutet
