Composite Restoration of Class II Cavities in Primary Molars With or Without Pulpotomy. Prospective 24 Month Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Modified USPHS criteria
研究概览
简要总结
After 24 months:
- Investigation of the success rate of Class II composite resin restorations in primary molars that have undergone pulpotomy.
- Comparison of Class II composite resin restorations in primary molars that have undergone pulpotomy with restorations of the same type in the same patient, in which no pulpotomy has been performed.
The null hypothesis of the study is that there is no statistically significant difference in the success of Class II resin restorations after their placement in primary molars, regardless of whether a pulpotomy has been performed or not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy children aged 3-9 years
- •At least one pulpotomy in a carious primary molar requiring a Class II resin restoration
- •At least one Class II cavity in a carious primary molar in the same patient that requires a resin restoration
- •The teeth to be restored must not present clinical signs of pulp necrosis, such as pathological mobility or abscess/fistula
- •Parents have signed an informed consent form
- •The young patients return for evaluation at 12 and 24 months
- •There is no exfoliation or extraction of the evaluated teeth before the 24-month period
排除标准
- 未提供
结局指标
主要结局
Modified USPHS criteria
时间窗: Assessment is done at 12 and 24 months following placement of the composite restoration
Modified USPHS criteria are variations of the original United States Public Health Service criteria used in dentistry to clinically evaluate restorations. They include the following criteria: marginal adaptation, retention, marginal discoloration, and secondary caries, with specific parameters and scoring scales adjusted for a particular study or material being evaluated. These modifications allow for a more precise assessment of dental restorations by tailoring the evaluation to specific clinical situations or restorative materials
次要结局
未报告次要终点
研究者
Nikos Lygidakis
Dr
Lygidakis Dental Clinic