"Comparison of the Effects of Resin Infiltrant, Fluoride Varnish, and the Combined Application of Resin Infiltrant and Fluoride Varnish on Primary Molars in the Treatment of Proximal Non-Cavitated Carious Lesions in Children."
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Caries Lesion Progression
研究概览
简要总结
Purpose:
This randomized controlled clinical trial aimed to compare the effectiveness of fluoride varnish, resin infiltrant, and their combination in treating superficial proximal carious lesions in primary molars of children aged 4 to 9 years.
Materials and Methods:
Twenty-six children with initial proximal caries (E1, E2, D1) on primary molars were randomly assigned to three groups: fluoride varnish only (F), resin infiltration only (RI), and resin infiltration combined with fluoride varnish (RI+F). Treatments were applied according to standardized protocols, and clinical and radiographic evaluations were conducted at 3, 6, 9, and 12 months.
详细描述
This randomized controlled clinical trial investigates the comparative effectiveness of fluoride varnish, resin infiltrant, and their combined use in managing superficial proximal carious lesions in primary molars of children aged 4 to 9 years. A total of 26 pediatric patients presenting with initial proximal caries lesions classified as E1, E2, and D1 levels were enrolled. Participants were randomly allocated into three groups: fluoride varnish only (F), resin infiltration only (RI), and a combination of resin infiltration with fluoride varnish (RI+F).
Interventions were applied according to standardized clinical protocols. Follow-up assessments, including clinical examinations and radiographic evaluations, were conducted at 3, 6, 9, and 12 months post-treatment to monitor lesion progression or regression. The primary outcome measure was the change in caries lesion status over time, evaluated through clinical and radiographic criteria.
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
- None
盲法说明
This study was conducted as an open-label trial. Neither participants, investigators, nor outcome assessors were blinded to group assignments due to the nature of the interventions.
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 4 and 9 years
- •Presence of initial proximal carious lesions (E1, E2, D1) on primary molars
- •Generally healthy children without systemic diseases
- •Consent obtained from parents or legal guardians
排除标准
- •Cavitated or advanced proximal carious lesions
- •Known allergy to fluoride varnish or resin infiltrant materials
- •Systemic diseases affecting oral health or participation
- •Prior restorative treatment on the target teeth
研究组 & 干预措施
Fluoride Varnish Group
Participants in this group receive only fluoride varnish applications according to standard clinical protocols. The treatment aims to remineralize early proximal carious lesions and prevent progression.
干预措施: Fluoride Varnish (Drug)
Resin Infiltration Group
Participants in this group receive resin infiltration treatment alone, applied following manufacturer guidelines and standardized procedures, aiming to arrest or reverse early enamel carious lesions.
干预措施: Fluoride Varnish (Drug)
Resin Infiltration + Fluoride Varnish Group
Participants in this group receive a combined intervention of resin infiltration followed by fluoride varnish application. The combined treatment is intended to maximize caries arrest and promote remineralization of proximal lesions.
干预措施: Fluoride Varnish (Drug)
结局指标
主要结局
Caries Lesion Progression
时间窗: 12 months
The primary outcome is the clinical and radiographic assessment of proximal carious lesion progression or arrest in primary molars over a 12-month follow-up period. Lesion status will be evaluated at 3, 6, 9, and 12 months to determine treatment efficacy.
次要结局
未报告次要终点
研究者
Sacide Duman
Associate Professor
Inonu University