The Color Masking Potentials of a Bioactive Glass Adhesive and the Resin ICON on the White Spot Lesions. A Comparative Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Color masking potential of ICON material in white spot lesions in permanent teeth.
研究概览
简要总结
The non cavitated white-spot lesion (WSL) occurs after sometime during fixed orthodontic treatments, and their treatment is mandatory before going into frank cavitation. The resin infiltration material (ICON, DMG, America) is considered to be the gold standard resin infiltrationmaterial used for WSL treatment. It is an efficient material in arresting WSLs and has high favorable esthetic recovery. Furthermore, biomaterials like bioactive glass adhesives HI-bond universal adhesive have always been used for replacement, repair and generation of dental hard tissues. The hypotheses of this study are:
- There will be no differences in color masking effect on WSLs managed by bioactive glass adhesive or ICON resin infiltration.
- There will be no significant addition of mineral content into WSLs after treating it with bioactive glass adhesive HI-Bond universal or with ICON.
详细描述
After sample size calculations were carried out a total sample size of 150 teeth will be included (75 teeth will be treated with ICON; and 75 other teeth will be treated with HI-Bond universal].
Split mouth study design involves treating WSLs in two different quadrants in each participant. Treatments will be done according to manufacturer's instruction. The WSLs in the teeth of one quadrant will receive treatments with the ICON (DMG, America) , and the others in the opposite quadrant will receive treatments with the bioactive glass adhesive HI-Bond universal (MEDICLUS, south Korea).
Before receiving the treatment, the WSLs will be tested at baseline by Quantitative light-induced fluorescence (QLF) device then the test will be repeated at 1-month after the treatment for the quadrant that received bioactive glass adhesive.
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)
盲法说明
The patients who participated in the study and the assessor of the treatment outcome did not know the type of treatment procedure received.
入排标准
- 年龄范围
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with teeth and WSL fullfiling the following criteria will be included in the study:
- •Anterior and premolar maxillary and mandibular teeth.
- •Teeth with no previous restorations.
- •post-orthodontic white spot lesions WSL with no adjacent restorations in the same tooth.
- •WSL on Labial surfaces of maxillary or mandibular anterior and premolars teeth.
排除标准
- •The following will be excluded from the study,
- •Cavitated enamel surface that requires direct composite restorations.
- •Presence of developmental enamel defects on the proposed teeth.
- •Diabetic patients and patients with metabolic syndrome.
- •Pregnant ladies.
- •Smoker patients.
研究组 & 干预措施
ICON resin group
Clean the white spot with prophylactic paste and then infiltrate the lesion with ICON resin.
干预措施: Icon Infiltrant (Drug)
Bioactive resin group
Clean the white spot with prophylactic paste and then infiltrate the lesion with bioactive resin.
干预措施: Bioactive infiltrant (Drug)
结局指标
主要结局
Color masking potential of ICON material in white spot lesions in permanent teeth.
时间窗: 6 months
Photographs will be taken before, immediately after treatment, and 1-month after treatment. These photographs will be used for evaluating of the esthetic outcome by two groups of subjects. The first group comprises the patients themselves. The second group includes dentists. Participants in the evaluation process will will be based on a 100-mm visual analogue scale (VAS). Participants will draw a line on the scale indicating their satisfaction. A line drawn between 0 - 5 cm will mean unsatisfactory outcome while that drawn between 5 - 10 cm will indicate satisfactory outcome.
Color masking potential of HI-Bond universal material in white spot lesions in permanent teeth.
时间窗: 6 months
Photographs will be taken before, immediately after treatment, and 1-month after treatment. These photographs will be used for evaluating of the esthetic outcome by two groups of subjects. The first group comprises the patients themselves. The second group includes dentists. Participants in the evaluation process will will be based on a 10-cm visual analogue scale (VAS). Participants will draw a line on the scale indicating their satisfaction. A line drawn between 0 - 5 cm will mean unsatisfactory outcome while that drawn between 5 - 10 cm will indicate satisfactory outcome.
次要结局
- The remineralisation potential of HI-Bond universal material of white spot lesion (WSL) in permanent teeth.(3 months)
- The remineralisation potential of HI-Bond universal material in the deepest point of the white spot lesion (WSL) in permanent teeth.(3 months)
- The remineralisation potential of HI-Bond universal material on lesion area (pixels) of white spot (WSL) in permanent teeth.(3 months)