Clinical performance of Equia FIL GC® high-density glass ionomer compared to Nu Alloy® amalgam restorations in patients with disabilities with symptomless caries: 26 month evaluation randomized controlled trial.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 73
研究概览
简要总结
Research question: How is the clinical performance of high-density glass ionomers compared to amalgam restorations on occlusal lesions in patients with disabilities at 3, 12 and 26 months after treatment? Participant characteristics: 77 people with an impairment or disability that allows adaptation measures in dental care, age from 12 to 59 years, with occlusal caries lesions on two molars of opposite arches were randomly assigned Equia FIL GC high-density glass ionomer as intervention and Amalgam Nu Alloy as control Key results: To assess clinical performance of restorations we used Modified USPHS /Ryge clinical criteria. That includes as clinical parameters: Marginal adaptation, anatomic form, surface roughness, secondary caries, restoration luster and marginal staining. And considers ALPHA values when the restoration is in excellent condition on specific parameters and it is expected to last for a long time Preliminar results with statistical significance at 3 months after treatment: - Amalgam restorations only showed decrease in “Marginal adaptation” parameter. - Glass ionomer showed better values on “Anatomic form” and worse values on “Surface roughness” and “Marginal adaptation” - In “Restoration luster” and “Anatomic form” glass ionomers showed more ALPHA values than Amalgam restorations Limitations: Study follow-up time
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 12 Years 至 59 Years(—)
- 性别
- All
入选标准
- •People with an impairment or disability that allows adaptation measures in dental care.
- •- Age from 12 to 59 years.
- •- People with permanent teeth who had ICDAS 4 or 5 occlusal caries lesions on two molars of opposite arches that require restorative treatment
- •- teeth that were symptomless and vital,
排除标准
- •- Adverse medical history,
- •- People with severe or potential behavioral problems.
