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临床试验/NCT04373356
NCT04373356已完成不适用

Non-invasive and Minimal Intervention in Dental Caries Management: Randomized Clinical Study

Western University, Canada2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Caries lesion progression

研究概览

简要总结

Clinical trial to compare non-invasive and minimally-invasive therapies on the progression of the caries lesions. Clinical investigation of resin infiltration versus sodium fluoride (5% NaF) varnish application.

详细描述

Dental caries is the most globally prevalent disease that affects thousands of adults and children. Caries is a biofilm-mediated, sugar-driven, multifactorial, and dynamic disease that results from the imbalance between demineralization and remineralization of the dental hard tissues. Preventing the onset of the disease should be the primary goal; however, once the disease is present efforts should be made by both patient and clinician to successfully reestablish the mineralization balance by the use of preventive and/or minimally-invasive methods when possible. The sodium fluoride (5% NaF) varnish is one of the most common therapies used as a non-invasive approach for caries prevention and remineralization; and, the resin infiltration materials are indicated for the minimal intervention of non-cavitated occlusal and proximal caries. The minimal intervention has been considered the new concept of caries management. Although several studies discussing minimal intervention or non-intervention are available, there is a lack of published randomized controlled trials (RCTs) providing data about the use of non-invasive therapies on incipient lesions, and its correlation with the patient's caries risk. The aim of this study is to evaluate the efficacy non-invasive and minimally-invasive therapies on the progression of the caries lesions considering the patient's caries risk.

This study will be conducted in the province of Ontario, Canada. A total of thirty patients (15 to 50 years old), who present with a minimum of two incipient proximal carious lesions on the proximal surfaces of posterior teeth (non-cavitated lesions identified as small, faint radiolucent areas seen on the intra-oral radiographs) will be asked to participate in this study. The radiologic assessment of incipient lesions will be performed by a dental radiologist, blinded to the selected treatment groups, by comparison of the radiographs imaging over time.

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
15 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients must present at least two non-cavitated proximal caries lesions
  • Patients must be able to give informed consent in English
  • Patients must be resident in London, Ontario, or nearby locales with community fluoridation

排除标准

  • Patients presenting proximal caries that are beyond the outer third of dentin
  • Patients suffering from a disability that impairs dental hygiene performance
  • Patients that are unable to perform her/his own oral hygiene

结局指标

主要结局

Caries lesion progression

时间窗: One year follow up

Evaluate caries lesion progression after using DMG Icon-infiltrative resin and/or 5% NaF Varnish by comparison of baseline and one year post-treatment radiographics.

次要结局

  • Caries risk assessment(One year follow up)

研究者

发起方
Western University, Canada
申办方类型
Other
责任方
Sponsor

研究点 (2)

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