Clinical Evaluation of White Spot Lesions Treated by S-PRG Coating Material and Resin Sealants in Comparison With Resin Infiltration by Using Spectrophotometer and Laser Fluorescence. (A Randomized Controlled Trial) (WSLs)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- patients tooth color change
研究概览
简要总结
Randomized with (1:1) prospective, double-blind, controlled trial. Subjects will be randomized to receive S-PRG and the control group receives ICON.
详细描述
Interventions: - All the procedures will be performed by the same clinician. DIAGNOdent will be used to assess the fluorescence loss of WSLs and the adjacent sound enamel. WSLs in permanent teeth will be treated according to the manufacturer's instructions with:
- Group I (Control group): 20 teeth will be treated with ICON.
- Group II ( EXPERIMENTAL) : 20 teeth will be treated with PRG BarrierCoat.
Observation: - The treatment methods will be assessed immediately after the intervention, 3 months,6 months, and one year. The data will be collected for evaluation of the difference in color and fluorescence loss between the treatment groups, by using DIAGNOdent devices, over different time intervals.
Ethical considerations
The research protocol is approved by the ethical committee, Faculty of Dental Medicine, Al-Azhar University and the enrolled patients should sign a written consent form.
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, Investigator)
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients within 20-40 years of age.
- •Each patient has 4 or more WSLs.
- •Mild and moderate WSLs according to Gorelick's scale.
- •Good oral hygiene and willing patients who can attend the study visits.
- •a Symmetrical number of permanent teeth in each arch (mesial to second molars).
排除标准
- •Active carious lesions.
- •Facial surface restorations.
- •Intrinsic and extrinsic stains.
- •Patients who have a significant medical history or if they smoke.
- •Criteria for discontinuation; Mortality and acquiring severe debilitating disease
研究组 & 干预措施
Icon resin infiltration material
Smooth surface resin infiltration comprises three steps for resin infiltration; Icon etch, Icon dry, and Icon infiltrant
干预措施: Giomer (Other)
Icon resin infiltration material
Smooth surface resin infiltration comprises three steps for resin infiltration; Icon etch, Icon dry, and Icon infiltrant
干预措施: Two composite resin sealants (Other)
PRG Barrier Coat
fluoride-releasing coating material containing surface reaction-type pre-reacted glass-ionomer (S-PRG) fillers
干预措施: Two composite resin sealants (Other)
Permaseal composite resin sealant
Permaseal unfilled composite resin sealants
干预措施: Giomer (Other)
Optiguard
Optiguard unfilled composite resin sealant
干预措施: Giomer (Other)
结局指标
主要结局
patients tooth color change
时间窗: 1 year
Color change with Vita Easyshade When the Delta E increased, it consider esthetic improving
次要结局
- patients tooth caries lesion state(1 year)
研究者
Mohamed Wakwak
Assistant professor
Al-Azhar University