Performance of Different Resin Infiltration Materials on White Spot Lesions: Clinical and Laboratory Assessments
试验速览
- 阶段
- 不适用
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- fracture of enamel.
研究概览
简要总结
The study is a clinical controlled trial. Ethical approval will be obtained from Imam Abdulrahman bin Faisal University, Dammam. The study participants will be recruited from the dental hospital and conducted between November 2020 to November 2020. This will be a single-center, randomized, single blinded with a 1:1:1 allocation ratio for the application of Icon® resin infiltration, MI Paste Plus and both treatments
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are willing and able to observe good oral hygiene and attend for the study visits.
- •Subjects with ≥1 visible and accessible early caries lesion present.
- •No prior white spot lesion treatment utilized except tooth brushing with fluoridated toothpaste.
排除标准
- •Active carious lesions
- •Facial surface restorations
- •Deciduous teeth
- •Enamel alteration (fluorosis, opacity, hypocalcification, hypoplasia)
- •Intrinsic and extrinsic strains
- •Physically and mentally challenged volunteers
- •Patients with systemic diseases under medication
结局指标
主要结局
fracture of enamel.
时间窗: Change from 0 day, 1 month and 6 months
Number of fracture assessed by enamel surface analysis via silicone replicas using CLSM
Color improvements
时间窗: Change from 0 day, 1 month and 6 months
Pre-treatment and post-treatment color changing (L\*A\*B values) of digital photographs using the Commission Internationale de l'Eclairage (CIE) system
Patient self satisfaction
时间窗: Change from 0 day, 1 month and 6 months
Post-treatment patient satisfaction using the patient satisfaction scale
Change in lesion status
时间窗: Change from 0 day, 1 month and 6 months
Post-treatment change in caries lesion status using ICDAS II
Cracks of enamel.
时间窗: Change from 0 day, 1 month and 6 months
Number of cracks assessed by enamel surface analysis via silicone replicas using CLSM
Microbial composition.
时间窗: Change from 0 day, 1 month and 6 months
Pre-treatment and post-treatment microbial composition of plaque samples. Samples will be stored at -80 °C until DNA extractions will be performed and run the 16S rRNA sequencing.
Effects on clinical parameter: sensitivity to percussion
时间窗: Change from 0 day, 1 month and 6 months
Pre-treatment and post-treatment effects on sensitivity to percussion by end blunted instrument.
Effects on clinical parameter: prolonged response to hot or cold.
时间窗: Change from 0 day, 1 month and 6 months
Pre-treatment and post-treatment effects on response to hot or cold by cold test
esthetic improvement
时间窗: Change from 0 day, 1 month and 6 months
Esthetic improvement through objective assessments using a visual analogue
Patient esthetic self perception
时间窗: Change from 0 day, 1 month and 6 months
Pre-treatment esthetic self perception by the subjects using questionnaire
change in lesion size
时间窗: Change from 0 day, 1 month and 6 months
Pre-treatment and post-treatment white spot lesion size
次要结局
未报告次要终点
研究者
Jumanah Aljishi
Dental intern
Imam Abdulrahman Bin Faisal University