A Randomized Split-Mouth Controlled Clinical Trial Comparing Resin Infiltration and Microabrasion for the Treatment of Early Caries Lesions in Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in lesion area ratio (R) after treatment
研究概览
简要总结
This study aims to evaluate and compare the clinical characteristics and treatment outcomes of early caries lesions using resin infiltration (Icon) and microabrasion (Opalustre). Early enamel lesions (ICDAS codes 1-2) often present as white spot lesions, which can compromise esthetics and may progress if untreated. This randomized split-mouth clinical trial will be conducted in patients presenting with at least two affected anterior teeth. Each patient will receive both interventions in different teeth, allowing direct intra-individual comparison. Outcomes will be assessed immediately after treatment and at 6 months to determine effectiveness in lesion improvement, esthetic appearance, and patient-related responses. The findings aim to provide evidence for minimally invasive management of early caries lesions.
详细描述
Early caries lesions, commonly manifested as white spot lesions, represent subsurface enamel demineralization without cavitation. These lesions are frequently observed in patients with plaque accumulation or undergoing orthodontic treatment and may progress if not managed appropriately. Minimally invasive approaches, such as resin infiltration and microabrasion, have been proposed as effective treatment strategies to arrest lesion progression and improve esthetic outcomes.
This study is designed as a randomized split-mouth controlled clinical trial to compare the effectiveness of resin infiltration (Icon, DMG, Germany) and microabrasion (Opalustre, Ultradent, USA) in the management of early caries lesions classified as ICDAS codes 1 and 2. The study will be conducted at Can Tho University of Medicine and Pharmacy Hospital.
Eligible participants will include patients aged 9 years and older presenting with at least two early caries lesions on anterior teeth. A split-mouth design will be applied, where each patient receives both interventions on different teeth, allowing intra-subject comparison and minimizing inter-individual variability.
For the resin infiltration group, the procedure includes enamel conditioning with hydrochloric acid (Icon Etch), ethanol drying (Icon Dry), and application of infiltrant resin followed by light curing. For the microabrasion group, treatment involves the application of hydrochloric acid and abrasive particles (Opalustre) using a rotary instrument under controlled conditions.
Clinical assessments will be performed at baseline (T0), immediately after treatment (T1), and at 6-month follow-up (T2). The study will evaluate changes in lesion characteristics, esthetic improvement, and patient-reported outcomes. Data will be analyzed using appropriate statistical methods to compare treatment effectiveness between the two interventions.
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
Outcome assessors evaluating clinical images and treatment results are blinded to the intervention allocation to minimize assessment bias.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 12 to 18 years
- •Presence of at least two early caries lesions (ICDAS codes 1-2) on the labial surfaces of anterior teeth (maxillary or mandibular incisors and canines)
- •Patients who are willing to participate and provide informed consent (or consent from parent/guardian for minors)
排除标准
- •Teeth that have undergone endodontic treatment at the study site
- •Teeth with existing restorations or requiring restorative treatment at the lesion site
- •Patients with systemic conditions or oral conditions that may affect enamel integrity or interfere with treatment outcomes
- •Patients who are unable to comply with follow-up visits
研究组 & 干预措施
Microabrasion (Opalustre)
Teeth assigned to this arm will be treated using a microabrasion technique (Opalustre, Ultradent, USA). A slurry containing 6.6% hydrochloric acid and silicon carbide particles is applied to the lesion surface using a rotary instrument at approximately 500 rpm for 60 seconds per application. The surface is rinsed and the procedure may be repeated as needed. Final polishing is performed after achieving satisfactory clinical results.
干预措施: Microabrasion (Device)
Resin Infiltration (Icon)
Teeth assigned to this arm will be treated using a resin infiltration technique (Icon, DMG, Germany). The procedure includes enamel conditioning with 15% hydrochloric acid (Icon Etch) for 120 seconds, followed by rinsing and drying with ethanol (Icon Dry). Resin infiltrant is then applied to the lesion surface for 3 minutes and light-cured for 40 seconds. A second application is performed for 1 minute followed by light curing. The surface is then polished to complete the procedure.
干预措施: Resin Infiltration (Device)
结局指标
主要结局
Reduction in lesion area ratio (R) after treatment
时间窗: Baseline (T0), immediately after treatment (T1), and 6 months after treatment (T2)
The primary outcome is the change in the lesion area ratio (R), defined as the percentage of the lesion area relative to the total labial tooth surface area, measured using standardized intraoral photographs and image analysis software. Measurements will be performed at baseline and follow-up to assess the effectiveness of the interventions.
次要结局
- Change in ICDAS score(Baseline (T0), immediately after treatment (T1), and 6 months after treatment (T2))