Effectiveness of Transillumination-Guided Surface Pretreatment on Aesthetic Masking and Resin Infiltration Time in MIH-affected Incisors (A Randomised Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- change in aesthetic masking effectiveness
研究概览
简要总结
Background: Resin infiltration often shows unpredictable outcomes in teeth affected by molar incisor hypomineralisation (MIH) due to variable enamel porosities, hypermineralised surface layers, and elevated protein content. Different pretreatment modalities alongside modified resin infiltration protocols have been suggested to enhance aesthetic masking and the required resin infiltration time.
Aim: To compare the effectiveness of transillumination-guided 5.25% NaOCl pretreatment following macroabrasion, with macroabrasion alone, each with 10-second hydrochloric acid (HCl) etching intervals, on aesthetic masking and resin infiltration time required in MIH-affected incisors.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy children with MIH-related mild white creamy opacities on permanent incisors, code 1 according to the European Academy of Paediatric Dentistry (EAPD) criteria.
- •Clinically detectable isolated lesions (whether homogeneous or heterogeneous on the incisal and middle thirds of the buccal surface of the selected teeth.
- •Patients with score 3 (positive) or score 4 (definitely positive) according to Frankl behavioral rating scale
- •Parents or legal guardians accepting to sign a written consent and join the study
排除标准
- •MIH-affected permanent incisors with post-eruptive enamel breakdown, cavitated lesions, restorations, or previously treated with surface layer removal or remineralising agents in the previous six months.
- •Children with an allergy history
研究组 & 干预措施
Test Group
干预措施: macroabrasion followed by oxidative pretreatment (Other)
Control Group
干预措施: macroabrasion alone (Other)
结局指标
主要结局
change in aesthetic masking effectiveness
时间窗: up to 6 months
Transillumination images (T0, Tx, Tmax) will be imported into ImageJ (National Institutes of Health, MD, USA), resized, and superimposed to align the labial surfaces. The labial surface and opacity will be manually outlined to measure their respective surface areas. The opacity area ratio will then be calculated as: R = (AO × 100) / AL, where AO is the opacity area and AL is the total labial surface area
次要结局
- change in color stability(up to 6 months)
- Changes in the patient-reported SCASS scores(up to 6 months)
- change in patient satisfaction(up to 6 months)