Evaluation of Enamel Resistance to White Spot Lesion Formation Around Orthodontic Brackets After CO2 Laser Irradiation: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Change in the Percentage of White Spot Lesion Area
研究概览
简要总结
This study aims to evaluate the clinical effect of CO2 laser on enamel resistance to white spot lesions formation around orthodontic brackets.
25 patients needing fixed orthodontic treatment will participate in the study, the CO2 laser will be applied in a split mouth design around orthodontic brackets in two contrast quarters of mouth in every patient and the other quarters will serve as a control. The white spot lesion formation will be monitored around the brackets during the orthodontic treatment after four and twelve weeks of irradiation with laser.
详细描述
Prior to enrollment of each subject into the study, they will be examined completely to determine the orthodontic treatment plan. The operator will inform them about the aim of the study and ask them to provide a written informed consent.
Before brackets' bonding (T0) the operator will evaluate with intraoral clinical examination and take intraoral photographs and evaluate with DIAGNOdent. Then after brackets' placement on teeth, the CO2 laser will be applied to the area of enamel about 2 mm of width around orthodontic brackets in a split mouth design. To blind the intervention sides on patients the control sides will receive nontherapeutic light.
Then intraoral photographs will be taken and the teeth will be assessed with DIAGNOdent (T1).
All patients will be trained to brush their teeth with a tooth paste containing 1100 ppm of fluoride twice a day. After 4 weeks of irradiation (T2) the patients will be examined for white spot lesions formation by clinical examination using Geiger index, photographic examination using AutoCAD 2009 evaluating formation and area percentage of white spot lesions, and the degree of demineralization will be assessed with DIAGNOdent. The all exams will also be done after 12 weeks of irradiation (T3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The non-irradiated side of the mouth will receive a placebo light (i.e. not the laser beam).
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with permanent occlusion at age 15-25 years.
- •No previous orthodontic treatment
- •Good oral hygiene
- •Need to orthodontic treatment with fixed appliances
排除标准
- •Patients with systemic diseases or syndromes
- •Patients with existence of enamel fluorosis
- •Patients with existence of amelogenesis imperfecta or hypocalcified enamel
- •Patients with existence of restorations or crowns or carious lesions on the labial surfaces of teeth.
- •Patients who received fluoride treatment within the last three months prior to being enrolled in the study.
研究组 & 干预措施
CO2 Laser Irradiation
This group of patients will be treated by splitting the dental arches into four quadrants: upper right, upper left, lower right and lower left. Two quadrants will receive the CO2 laser irradiation whereas the remaining two quadrants will receive no treatment (i.e. the placebo light).
干预措施: CO2 laser irradiation (Radiation)
Placebo
A placebo light will be used as if the patient is irradiated with the laser beam.
干预措施: Placebo (Other)
结局指标
主要结局
Change in the Percentage of White Spot Lesion Area
时间窗: Percentage of white spot lesion area will be assessed at 10 minutes before taking the impressions (T0), five minutes following brackets' placement and irradiation (T1), at four weeks after irradiation (T2) and at twelve weeks after irradiation (T3)
This will be assessed using digital images.The percentage of white spot lesion area to the area of the labial surface of the tooth on digital images will be calculated using AutoCAD 2013 program.
Change in White Formation Status we will evaluate the degree of demineralization by DIAGNOdent Pen around the orthodontic brackets.
时间窗: The status of white spot formation will be judged at 10 minutes before taking the impressions (T0), five minutes following brackets' placement and irradiation (T1), at four weeks after laser irradiation (T2) and at twelve weeks after irradiation (T3)
This will depend on the presence or absence of white spot formation assessed clinically.
Change in the Extent of White Spot Formation
时间窗: Extent of white spot formation will be measured 10 minutes before taking the impressions (T0), five minutes following brackets' placement and irradiation (T1), at four weeks after laser irradiation (T2) and at twelve weeks after laser irradiation (T3)
This will be assessed clinically using Geiger index (Step 1: no white spot lesions, Step 2: the white spot lesion is less than the third of the tooth surface area, Step 3: the white spot lesion is more than the third of the tooth surface area, Step 4: severe white spot lesions and caries)
Change in the degree of demineralization
时间窗: The degree of demineralization will be evaluated at: t 10 minutes before taking the impressions (T0), five minutes following brackets' placement and irradiation (T1), at four weeks after irradiation (T2) and at twelve weeks after irradiation (T3)
The degree of demineralization will be evaluated by DIAGNOdent Pen around the orthodontic brackets.
次要结局
未报告次要终点