A Multi-center, Randomized-controlled, 12-month, Split-mouth, Non-inferiority Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy With a Flowable Bulk Fill Composite in Class I and II Deciduous Teeth
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Postoperative pain
研究概览
简要总结
The overall aim of this clinical investigation is to assess the clinical performance and safety of composite restorations cured with fast curing mode (5 seconds with 2000 mW/cm²) in primary molars.
详细描述
Dental interventions in young children are challenging due to limited compliance and anxiety. Moisture control during the placement of resin composite fillings is particularly difficult, as children need to remain calm. Reducing treatment time benefits both children and dentists.
The planned clinical investigation aims to evaluate the clinical performance and safety of posterior restorations on primary teeth using a flowable composite with a fast curing mode (5 seconds, 2000 mW/cm²) compared to a conventional curing mode (10 seconds, 1200 mW/cm²).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent of a legal representative (usually parents)
- •2 deciduous molars in the need of direct filling therapy class I and/or II in different quadrants (primary or secondary caries, filling loss)
- •Classification of caries: caries of all sizes in deciduous molars are included unless they can be treated with fissure sealing (ICDAS 3, 4, 5)
- •Sufficient language skills of legal representative and children
- •Teeth in the need of indirect pulp capping if necessary (Operator decision)
排除标准
- •Cognitive impairment not age-appropriate
- •Sensitive tooth (pain at night, irritation-persistent pain, buccal swelling, percussion sensitivity)
- •Teeth with severely resorbed roots (anormal tooth mobility)
- •Direct pulp capping
- •Pulpotomy of an adjacent tooth in the same appointment
- •Noncompliant child
- •Allergies to material or anaesthetics used in the study
- •Sufficient isolation not possible
结局指标
主要结局
Postoperative pain
时间窗: 4-10 days after placement of the dental fillings
The assessment of postoperative pain will be done by using the Wong-Baker Faces Pain rating Scale and includes questions about type and duration of pain, intensity of pain and the type of stimulus causing the pain. Values of 0 and 2 in the Wong-Baker Faces Pain Rating Scale are considered as no pain and values \>2 as pain.
次要结局
未报告次要终点