Principal Investigator,Resident at Cairo University
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 330
- 主要终点
- incidence of white spot lesions using DIAGNOdent
研究概览
简要总结
white spot lesions are a common problem and are reported in up to 96% of orthodontic patients. In this study, the preventive effect of bioactive gel is evaluated in comparison to fluoride.
详细描述
Dental caries is a chronic infectious disease present worldwide and is among one of the most common oral diseases. It is a multifactorial disease resulting from imbalance between demineralization and remineralization initiated by acid producing bacteria in the microenvironment.
The incipient form of caries, white spot lesions (WSL), is characterized by primitive enamel surface and subsurface demineralization and could be identified clinically by their chalky white appearance . Orthodontic treatment is a major risk factor for the development of WSL. They are reported in up to 96% of orthodontic patients.
Many materials are being used to prevent white spot lesions with fluoride being the most commonly used . New materials have been emerged such as giomer based bioactive gel with the ability to release six ions Fluoride inhibits demineralization and promotes deposition of fluoroapatite. Aluminum helps to decrease demineralization as well by forming Alumino fluoro complexes. Borate reduces biofilm formation beside its antibacterial effect.
Silica promotes remineralization by inducing apatite nucleation on the tooth surface. Strontium converts hydroxyapatite into strontium apatite thus increasing acid resistance and has an inhibitory effect on bacterial growth. Other ions such as Na act as strong base and have acid buffer capacity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
double
入排标准
- 年龄范围
- 15 Years 至 28 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients assigned for orthodontic treatment with fixed appliances
- •Sound teeth with fixed orthodontic appliances
- •Either maxillary or mandibular teeth or both
排除标准
- •Patients with poor oral hygiene
- •Allergic reaction to the materials used.
- •Lack of compliance.
- •xerostomia
- •Evidence of parafunctional habits.
- •Active carious lesions
- •Dental fluorosis
- •Hypocalcified teeth
- •Systemic diseases affecting teeth such as Amelogenesis imperfecta
- •Severe periodontal affection
研究组 & 干预措施
Application of bioactive gel on teeth in patients assigned for orthodontic treatment
Application of bioactive gel on labial/buccal surfaces of teeth is done according to manufacturer instructions using microbrush followed by light curing
干预措施: giomer based bioactive gel (Drug)
Application of Fluoride on teeth in patients assigned for orthodontic treatment
Application of fluoride gel will be done using a gel loaded tray held in the mouth for 4 minutes .After removal of tray ,patients must spit out the residual gel. The use of suction is a must to avoid the problem of over ingestion
干预措施: Fluoride gel (Drug)
结局指标
主要结局
incidence of white spot lesions using DIAGNOdent
时间窗: Baseline,change from baseline at 3 months,6 months,9 months and 12 months
the ability of the gels to prevent white spot lesions will be assessed using DIAGNOdent
次要结局
- incidence of white spot lesions using ICDAS (international caries detection and assessment system)(Baseline,change from baseline at 3 months,6 months,9 months and 12 months)
研究者
Farah Khaled El Hindawy
Prevention of white spot lesions in patients undergoing orthodontic treatment using bioactive gel versus fluoride gel
Cairo University
