Comparison of a Chemically Activated Composite Resin Alkasite With Resin Composite in Atypical Caries Lesions of Deciduous Teeth - A Non-inferiority Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- Survival of restoration
研究概览
简要总结
Atypical cavities, which involve more than two surfaces, one being buccal or lingual/palatal, are a challenge for restorative dentistry, since the risk of restorative failure is related to the number of surfaces involved. Thus, the purpose of this umbrella project is to conduct a randomized controlled trial (RCT) to evaluate the efficacy and patient-centered outcomes of a chemically activated composite alkasite resin in atypical deciduous molar lesions. Primary molars of children aged 4 to 7 years with at least one atypical cavitary lesion in primary molars will be selected for the RCT. The selected teeth will be randomly divided into: Alkasite chemically activated composite resin and Bulk fill composite resin. Clinical and radiographic follow-up of the lesions will be performed for 6 and 12 months. The effectiveness of the treatments will be evaluated by the longevity of the restorative procedures and paralysis of the lesions. Patient-centered outcomes will also be evaluated.
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 (Participant)
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children will be included who have at least one posterior tooth with atypical caries lesion.
排除标准
- •Patients with special needs will be excluded, with general health conditions that may affect the oral cavity, non-cooperating in relation to the examination, which use orthodontic apparatus and the parents/guardians or children not to consent to their participation in the study. In addition, teeth with pulp exposure, spontaneous pain, mobility, presence of swelling or fistula close to the tooth, furcation or cervical injury, teeth with restorations, sealants or enamel formation defects will be excluded.
结局指标
主要结局
Survival of restoration
时间窗: 12 months after treatment.
To evaluate the survival of restoration by clinical examination with FDI index.
次要结局
- Secondary caries lesion or on the surface adjacent to the restored tooth(12 months after treatment.)
- Operator perception(6 months after treatment.)
- Child discomfort(Immediately after the treatment.)
- Parents/Guardians Satisfaction(6 months after treatment.)
- Caries lesion progression(12 months after treatment.)
- Post Operative sensitivity of the child(7 days after treatment.)
- Perception of children and parents/guardians(6 months after treatment.)
- Oral health-related quality of life(6 months after treatment.)
研究者
Jose Carlos P Imparato
Principal investigator
Faculty Sao Leopoldo Mandic Campinas