Effects of Different Remineralization Agents on the Progression of Non-Cavitated Approximal Carious Lesions in Primary Teeth: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Radiographic progression of approximal caries lesions
研究概览
简要总结
Dental caries is a highly prevalent disease in children. Contemporary caries management emphasizes minimally invasive approaches that aim to arrest or reverse non-cavitated lesions rather than remove tooth structure. This randomized clinical trial aims to evaluate the effects of different remineralization agents on the progression of non-cavitated approximal carious lesions in primary teeth.
The study will be conducted in children aged 4-10 years presenting with non-cavitated approximal carious lesions in primary molars. Participants will be randomly assigned to treatment groups receiving silver diamine fluoride (SDF), a self-assembling peptide (P11-4), and/or 5% sodium fluoride (NaF) varnish. Materials will be applied according to manufacturers' instructions.
Lesion progression will be assessed using standardized bitewing radiographs obtained at baseline and follow-up visits. Radiographic evaluations will be performed by blinded investigators. In addition, potential tooth color changes associated with the treatments will be quantitatively measured using a spectrophotometer based on the CIE Lab* system at predefined follow-up intervals.
The findings of this study are expected to provide clinically relevant evidence regarding the effectiveness and aesthetic outcomes of contemporary non-invasive caries management strategies in primary teeth.
详细描述
This study is designed as a randomized, parallel-group clinical trial investigating the effects of different remineralization agents on non-cavitated approximal carious lesions in primary teeth.
The study population will consist of children aged 4-10 years with at least two non-cavitated approximal carious lesions (radiographically classified at the enamel or outer dentin level) in primary molars. After baseline clinical and radiographic examinations, eligible teeth will receive preventive treatment interventions.
Participants will be randomly allocated to treatment groups. Interventions include silver diamine fluoride (SDF), a self-assembling peptide (P11-4), and 5% sodium fluoride (NaF) varnish. All materials will be applied following manufacturers' recommendations and standard clinical procedures. Repeat applications will be performed at scheduled follow-up visits.
Lesion progression will be evaluated using standardized bitewing radiographs taken at baseline and follow-up periods. Radiographic assessments will be performed independently by blinded examiners using predefined scoring criteria. Changes in lesion status over time will be categorized as regression, stability, or progression.
To assess potential aesthetic effects of the treatments, tooth color measurements will be performed using a spectrophotometer under standardized conditions. Color parameters will be recorded according to the CIE Lab* color system at baseline and follow-up visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
In this split-mouth randomized clinical trial, the outcome assessor was blinded to the lesions' allocation to remineralization agents.
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4-10 years
- •Presence of at least two non-cavitated proximal caries lesions in primary teeth
- •Radiographic detection of lesions classified as E1, E2, or D1
- •Absence of systemic disease
- •Cooperative patients
- •Written informed consent obtained from parents or legal guardians
排除标准
- •Presence of restorations on study teeth
- •Deep dentin caries (D2 or D3)
- •Cavitated lesions
- •Uncooperative patients
- •Inability to attend follow-up visits
研究组 & 干预措施
P11-4 + NaF Varnish
Approximal carious lesions in primary teeth that were non-cavitated were treated with the self-assembling peptide P11-4, followed by 5% sodium fluoride varnish, using a randomized split-mouth design.
干预措施: P11-4 + NaF Varnish (Other)
Silver Diamine Fluoride
This study examined the treatment of non-cavitated approximal carious lesions in primary teeth with silver diamine fluoride using a randomized split-mouth design.
干预措施: Silver diamine fluoride (Other)
NaF Varnish Alone
Approximal carious lesions in primary teeth that were non-cavitated were treated with 5% sodium fluoride varnish alone in a randomized split-mouth design.
干预措施: NaF Varnish Alone (Other)
结局指标
主要结局
Radiographic progression of approximal caries lesions
时间窗: 6 months and 12 months after intervention
Lesion progression will be assessed using standardized bitewing radiographs and evaluated according to the E0-E2, D1-D3 radiographic scoring system. Changes in lesion status over time will be categorized as regression, stability, or progression based on predefined radiographic criteria.
次要结局
- Tooth color change (ΔE)(3 months, 6 months, and 12 months)
- Clinical lesion activity(3 months, 6 months, and 12 months)
研究者
Merve AKCAY
Professor, Department of Pedodontics
Izmir Katip Celebi University