Aesthetic Restorations in Deciduous Anterior Teeth - Study Protocol for a Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 194
- 主要终点
- Change in progression of caries lesion through clinical criteria and longevity of restorations
研究概览
简要总结
This study proposes to conduct a randomized clinical trial (RCT), composed of a sample of 194 deciduous central and lateral incisors with active cavitated lesions, simplified ICDAS C+ score, with involvement of more than two surfaces. This sample will be divided into two experimental groups, both with selective removal of carious tissue: a group in which conventional restoration will be performed using opaque resins; and another group with monochromatic resin with chameleon effect and polyvinyl crowns.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ranging in age from 12 to 60 months with at least one active cavitated caries lesion involving more than 2 surfaces (C+ score) in deciduous upper incisors will be included.
排除标准
- •Patients with special needs, with general health conditions that may affect the oral cavity, whose guardians do not sign the Inform Consent Form will be excluded. In addition, teeth with pulp exposure, spontaneous pain, mobility, presence of swelling or fistula near the tooth and teeth with previous restorations; less than 2/3 of root (radiographically assessed), teeth without an antagonist, teeth with previous restorations and children with bruxism and/or deep bite.
结局指标
主要结局
Change in progression of caries lesion through clinical criteria and longevity of restorations
时间窗: Baseline and after 6, 12, 18 and 24 months.
The integrity of the restoration, its adaptation in all dental faces and identified possible failures related to structural fracture, resin wear, maladaptation or functional maintenance of the restored tooth will be verified. The clinical evaluation of the retention of the restorations will be performed after 6, 12, 18 and 24 months, using the criteria: total retention; Partial retention 1 - presence of the resin in two thirds of the surface of each dental face; Partial retention 2 - presence of the resin in one third d and each face of the dental surface, total loss of resin on the surface of the dental surface. It will also be evaluated the degree of tooth mobility and its relationship with the usual exfoliation period in the teeth belonging to both groups. In teeth where the restoration is intact and clinical features of associated lesions are not verified, the lesions will be considered as inactive.
次要结局
- Change in the progression of caries lesion by radiographic criteria(Baseline and after 6, 12, 18 and 24 months.)
- Change in the perception of parents/guardians(Baseline and after 6, 12, 18 and 24 months.)
- Change in the satisfaction of parents/guardians(Baseline and after 6, 12, 18 and 24 months.)
- Change in the impact of treatments on children's oral health-related quality of life(Baseline and after 6, 12, 18 and 24 months.)
研究者
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho