Comparative evaluation of silver diamine fluoride (sdf) with and without light curing for managing moderate carious lesions in primary teeth : a randomized controlled study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- •To compare the effectiveness of Silver Diamine Fluoride (SDF) with and without light curing in controlling staging of moderate carious lesions limited to dentin in primary teeth as determined by clinical and radiographic examination.
研究概览
简要总结
Introduction
Dental caries is a prevalent infectious disease that leads to tooth structure disintegration. Traditional treatments such as restorative procedures and extractions can be traumatic, especially for children. Silver diamine fluoride (SDF) has gained attention as a minimally invasive option for caries prevention and arrest. The study aims to assess the impact of light curing on SDF efficacy in controlling moderate carious lesions in primary teeth.
Objective
The primary objective is to compare the effectiveness of SDF with and without light curing in arresting moderate carious lesions in primary teeth using clinical and radiographic evaluations. Secondary objectives include evaluating caries activity, parental satisfaction, and patient-reported pain and discomfort between the two techniques.
Methodology
A randomized controlled study will be conducted at the Department of Pediatric and Preventive Dentistry, King George’s Medical University. Pediatric patients aged 2-5 years with moderate-stage carious lesions will be randomly assigned to two groups:
- Group A (Intervention): SDF application followed by immediate light curing for 20-30 seconds.
- Group B (Control): SDF application without light curing.
Caries progression and activity will be assessed using clinical and radiographic examinations over 12 months. Parental satisfaction and patient discomfort will be evaluated using Likert and Visual Analogue Scales. Statistical analysis will be performed to determine the significance of differences between the groups.
Expected Outcome
It is anticipated that light curing will enhance the efficacy of SDF in controlling carious lesions by improving silver ion penetration, increasing dentin hardness, and potentially reducing lesion progression compared to SDF application alone.
Conclusion
The study aims to provide clinical insights into optimizing SDF application for pediatric patients. Findings may contribute to the development of a more effective, patientfriendly caries management protocol, particularly for young children and those with limited access to dental care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 2.00 Year(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with moderate/high caries likelihood as classified under ICCMS™ protocol.
- •(International Caries Classification and Management System).
- •2.Patients presenting with ‘moderate stage carious’ lesions (as per ICDAS merged categories) International Caries Detection and Assessment System on buccal/facial primary tooth surfaces in either maxillary or mandibular arch.
- •3.Uncooperative children with’ definitely negative’ or ‘negative’ behavioural rating according to Frankl behavioural rating scale.
- •4.Patients whose parents give consent to participate in the study.
排除标准
- •1.Patient presenting with only ‘initial/extensive stage carious’ lesions (as per ICDAS merged categories).
- •2.Patient with any metabolic disorder, medically compromised conditions.
- •3.Patient with tooth developmental defects/anamolies.
- •4.Patient with previous history of non-invasive/microinvasive caries management interventions.
- •5.Patients whose parents did not agree to participate in the study.
- •6.Patients with history of xerostomia or any condition that reduces salivary flow.
结局指标
主要结局
•To compare the effectiveness of Silver Diamine Fluoride (SDF) with and without light curing in controlling staging of moderate carious lesions limited to dentin in primary teeth as determined by clinical and radiographic examination.
时间窗: Clinical evaluation: T0 (baseline), T1 (three months post intervention), T2 (six months post intervention) and T3 (nine months post intervention), T4 (twelvemonths post intervention). | Radiographic evaluation: T0 (baseline), T2 (six months post intervention), and T3 (nine months post intervention), T4 (twelve months post intervention).
次要结局
- -Change in activity status of carious lesions from baseline(-Parental satisfaction during treatment)