NCT05638217已完成不适用
Prospective Cohort Study: Efficacy of the Use of 38% Silver Diamine Fluoride and 5% Sodium Fluoride Varnish in Patients 4 to 12 Years for the Treatment of Caries and Its Association With Other Aspects of Relevance
Universidad Mayor de San Simón1 个研究点 分布在 1 个国家目标入组 199 人开始时间: 2022年11月7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
- 199
- 试验地点
- 1
- 主要终点
- Ratio of arrested cavity lesions after treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish
研究概览
简要总结
The goal of this observational study is to identify the efficacy of silver diamine fluoride 38% followed by sodium fluoride varnish 5% in a population with untreated dental caries age range 4 to 12 years old. The main questions to answer are
- Efficacy of treatment of active tooth decay with the treatment protocol of 38% silver diamine fluoride and 5% sodium fluoride varnish.
- Clinical evaluation of tooth decay treated with 38% silver diamine fluoride and 5% sodium fluoride varnish in quality of hardness, color change and caries progression.
- Explore the association of treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish with: i. Reduction of oral pain caused by the presence of carious lesions. ii. Improvement in gingival oral health. iii. Changes in general nutritional status through measurements of height, weight, hemoglobin levels and nutritional survey. The participants will be identified, charted (with nutritional surveys and parameters), as well as treated and compared in a six- and twelve-month period, where researchers will clinically identify the association between the use of this protocol and the efficacy of such, as well as other related nutritional aspects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must be able to receive all necessary treatments and may be followed up for additional treatments and/or record follow-ups at each time point and for the duration of the study.
- •Children within the age range mentioned above.
- •Require a completed informed consent form and completed nutritional survey record for anyone who will participate in the program.
- •According to the evaluation of the dentist Caries grade I and grade II
- •In the case of patients with disabilities, at least one parent or legal guardian must be present at all times during the study.
排除标准
- •Patients who, after assessment, identify a pulp condition or abscess in any of the teeth, this affected piece will be excluded from receiving treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish (in these cases, the Patient Coordinator will refer to a dentist outside the study for their treatment)
- •Patients with caries with grade III or grade IV
- •Patients with a known allergy to any of the active ingredients ( 38% silver diamine fluoride and 5% sodium fluoride varnish)
- •Patients who were unable to give their informed consent or complete the nutritional survey.
- •Patients who cannot participate during the entire program (12 months).
- •Patients with other oral treatments (Orthodontics).
- •Patients who are not present with at least one parent or legal guardian at the time of treatment.
结局指标
主要结局
Ratio of arrested cavity lesions after treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish
时间窗: 12 months from treatment
The investigators will evaluate the efficacy of treatment of active cavity lesions after using the treatment protocol with 38% silver diamine fluoride and 5% sodium fluoride varnish. This evaluation will be performed by a trained dentist conducting an evaluation of multiple clinical findings including signs and symptoms of an active or arrested cavity.The clinical evaluation will be recorded in an odontograph for each patient.
次要结局
- Evaluate color change(12 months from initial treatment)
- Evaluation of the reduction of oral pain caused by the presence of carious lesions(12 months from initial treatment)
- Evaluate changes in height and weight(12 months from treatment)
- Evaluate changes in a nutritional survey(12 months from treatment)
- Evaluate hardness(12 months from initial treatment)
- Evaluate cavity progression of cavity treated(12 months from initial treatment)
- Evaluation the reduction of oral pain caused by the presence of carious lesions.(6 months from treatment)
- Evaluate Improvement in gingival oral health.(12 months from initial treatment)
- Evaluate changes in hemoglobin levels(12 months from treatment)
研究者
Rodrigo Arce Cardozo
Associate Research Professor
Universidad Mayor de San Simón
研究点 (1)
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