Reparación y Sellado de Restauraciones de Amalgama y Resinas Compuestas Para el Incremento de Su Longevidad Repair and Sealing of Amalgam and Composite Resins to Increase of Longevity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Marginal adaptation
研究概览
简要总结
the patient (n=60), with at least 3 composite resins with marginal defects , randomized into 3 groups A=Sealed with flow composite reinforced with nanofiller , B= Sealed with resin sealant , and C=Control, without intervention , and then assessed by the FDI criteria for clinical performance and longevity of restorations
详细描述
This is a prospective, double-blind randomized clinical trial under the recommendations of CONSORT. The statistical unit was considered the patient (n=60), with at least 3 composite resins with marginal defects , randomized into 3 groups A=Sealed with flow composite reinforced with nanofiller , B= Sealed with resin sealant , and C=Control, without intervention.
Inclusion criteria:
- Age 18 or older
- High risk of caries.
- With restorations of resin composite occlusal, molars or premolars, with values of 3 or 4 for the parameter marginal adaptation according to the FDI criteria.
Exclusion criteria:
- Patients with the impossibility of mouth opening or dental treatments.
- Patients with allergies to any of the materials used.
- The presence of adjacent to the restoration or secondary caries.
- Patients with prior sealed of their restorations.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The evaluated restorations will be coded, and the data will be delivered in sealed envelopes without any identification of the patient, the data will be processed without identification of the groups. The sealant and the resin will be the same color so the evaluator will not be able to differentiate the treatments
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older
- •High risk of caries.
- •With restorations of resin composite occlusal, molars or premolars, with values of 3 or 4 for the parameter marginal adaptation according to the FDI criteria.
排除标准
- •Patients with impossibility of mouth opening or dental treatments.
- •Patients with allergies to any of the materials used.
- •Presence of adjacent to the restoration or secondary caries.
- •Patients with prior sealed of their restorations.
结局指标
主要结局
Marginal adaptation
时间窗: 6 month
( mm of bridge between tooth and restorations )
Marginal staining,
时间窗: 4 years
( + \>50% diameter / - \<50% diameter)
Retention of seal ( is present + / was loose -)
时间窗: 4 years
Loss of restoration
次要结局
未报告次要终点
研究者
Eduardo Fernandez
Profesor
University of Chile