Effect of Ozone Therapy on the Remineralization of Initial Caries Lesions in Children: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Quantitative Light-Induced Fluorescence (QLF) fluorescence loss (ΔF) values of initial caries lesions
研究概览
简要总结
Initial caries lesions can be managed using non-invasive treatment approaches that promote remineralization and prevent lesion progression. Ozone therapy has been suggested as an adjunctive treatment because of its antimicrobial properties and its potential to enhance remineralization.
This randomized controlled clinical trial aims to evaluate the effect of ozone therapy on the remineralization of initial caries lesions in children. Participants will be randomly assigned to receive either ozone therapy followed by application of a remineralizing gel or application of the remineralizing gel alone.
Changes in lesion status will be assessed over time using clinical and optical evaluation methods. The results of this study may contribute to the development of evidence-based minimally invasive approaches for the management of early caries lesions in pediatric patients.
详细描述
Dental caries remains one of the most common chronic diseases affecting children worldwide. Initial non-cavitated caries lesions represent a reversible stage of the disease and provide an opportunity for non-invasive treatment through remineralization strategies.
Ozone therapy has attracted interest in pediatric dentistry because of its antimicrobial effects and its potential to improve conditions for remineralization. However, evidence regarding its clinical effectiveness as an adjunct to remineralizing agents remains limited.
The aim of this prospective randomized controlled clinical trial is to evaluate the effectiveness of ozone therapy in the management of initial caries lesions in children.
Eligible participants with initial non-cavitated caries lesions will be randomly allocated to one of two study groups. The intervention group will receive ozone therapy followed by application of ROCS Medical Minerals remineralizing gel, while the control group will receive ROCS Medical Minerals remineralizing gel alone.
Participants will be evaluated at baseline and during follow-up visits according to the study protocol. Changes in lesion characteristics and remineralization outcomes will be monitored using clinical and optical assessment methods.
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
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6-12 years. Presence of at least one initial non-cavitated caries lesion. Systemically healthy children. Frankl Behavior Rating Scale score of 3 or
- •Written informed consent obtained from the parent or legal guardian.
排除标准
- •Cavitated caries lesions requiring restorative treatment. History of allergy to any study material. Systemic diseases affecting oral health or salivary flow. Respiratory diseases (e.g., asthma) contraindicating ozone therapy. Use of medications affecting salivary flow or enamel remineralization. Uncooperative children (Frankl score 1 or 2). Parent or guardian unwilling to participate or unable to attend follow-up visits.
研究组 & 干预措施
Ozone Group
Participants receive ozone therapy followed by ROCS Medical Minerals gel application for the management of initial caries lesions.
干预措施: other (Other)
Control Group
Participants receive ROCS Medical Minerals gel alone for the management of initial caries lesions.
干预措施: other (Other)
结局指标
主要结局
Change in Quantitative Light-Induced Fluorescence (QLF) fluorescence loss (ΔF) values of initial caries lesions
时间窗: Baseline, Weeks 1, 2, 3, 4, and Week 8
Fluorescence loss (ΔF) values of each initial caries lesion will be assessed using the QrayCam Pro system at baseline and follow-up visits (Weeks 1, 2, 3, 4, and 8). The outcome will be reported as the change in ΔF values from baseline to each follow-up visit. Lower ΔF values indicate greater remineralization, reflecting reduced mineral loss.
次要结局
- Change in DIAGNOdent Pen laser fluorescence values of initial caries lesions(Baseline, Weeks 1, 2, 3, 4, and Week 8)
- Change in the clinical appearance of initial caries lesions assessed using standardized intraoral photographs(Baseline, Weeks 1, 2, 3, 4, and Week 8)
研究者
Neslihan Atmaca
Principal Investigator
Marmara University