Discomfort Evaluation During Atraumatic Restorative Treatment in Children- Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Discomfort evaluation with heart beat and oxygen saturation
研究概览
简要总结
This study evaluates the patient 's discomfort when submitted to partial caries removal through the atraumatic restorative treatment compared to chemo-mechanical caries removal using Papacarie™ gel.
详细描述
This study will evaluate the patient 's discomfort through oximeter (measuring the heart rate of the caries) prior to removal of the carious tissue, and when subjected to partial caries removal through the atraumatic restorative treatment compared to removal of chemo - mechanical caries with Papacarie gel ™.
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
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •normoreactive,
- •in good general health conditions,
- •cooperative during screening,
- •with at least one oclusal caries cavity in primary molars.
- •Caregivers and/or children's parents must accept and sign the consent form.
- •Children must accept their participation by nodding (assent).
排除标准
- •pulp exposition,
- •spontaneous pain,
- •mobility,
- •swollen area around the tooth,
- •furcation,
- •cervical lesion,
- •restorations,
- •sealants,
- •developmental defect of enamel.
研究组 & 干预措施
Atraumatic Restorative Treatment
Partial removal of carious tissue using manual instruments.
干预措施: Caries removal using only manual instruments (Other)
Chemo-mechanical Removal
Partial removal of carious tissue using manual instruments and the material Chemo-mechanical removal group using Papacarie™gel.
干预措施: Caries removal using Papacarie gel (Other)
结局指标
主要结局
Discomfort evaluation with heart beat and oxygen saturation
时间窗: Before the procedure (when the patient is in the dental chair and there is no intervention), and during the procedure (removal of the cavity tissue).
Discomfort evaluation with Wong-Baker
时间窗: immediately after treatment
The discomfort of each type of treatment will be evaluated using the facial scale of Wong-Baker (Wong, Baker, 1998). This scale indicates the discomfort of an individual who has to choose among six faces. The first image is a smiling happy face, indicating no discomfort, followed by gradually less cheerful expressions, up to the last one which is a very sad face covered by tears, indicating great discomfort. The participant will be asked to choose the face that is more similar to how he/she felt during the treatment immediately after the procedure. This answer should be given solely by the child, which means no parental or professional interference
次要结局
- Operators satisfaction(immediately after treatment)
- Time of restorative procedure(Will be evaluated the time required for removal of the caries tissue only with manual removal and when manual removal with the product Papacárie ™)
研究者
Jose Carlos P Imparato
Principal Investigator
Faculty Sao Leopoldo Mandic Campinas