Evaluation of Three Different Minimally Invasive Techniques for Management of Enamel Opacities in Patients With Molar Incisor Hypomineralization "Randomized Controlled Clinical Trial"
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Hypersensitivity
研究概览
简要总结
The controlled clinical trial will be done to evaluate Resin infiltration, Resin modified glass ionomer varnish and Light cured giomer varnish as minimally invasive techniques for management of enamel opacities of patients with molar incisor hypomineralization. Variation in mineral density of the enamel opacity , ,Hypersensitivity, Color change of the enamel opacity, Quality of life of the patient, Parent Satisfaction will be evaluated preoperatively and at 1, 3,6,12 and 18 months of follow up.
详细描述
A total of 75 patients will be selected according to the eligibility criteria from the Pediatric Dentistry and Dental Public Health outpatient clinic, Faculty of Dentistry, Ain Shams University.
A Full detailed medical and dental history will be obtained from the parent and a clinical examination will be performed using a dental mirror and a dental explorer under LED illumination and after dryness of the teeth to make sure that the patients fulfill the inclusion criteria.
After explaining the aim of the study, benefits, possible risks and rights to the patients and their parents. A signed informed consent of the parents as well as child's assent, outlined by the Ethical Committee, Faculty of Dentistry, Ain Shams University will be obtained prior to the conduction of the study. • The patients will be randomly equally allocated into three treatment groups (25 patients/ group): Group (A): patients will receive resin infiltration. Group (B): patients will receive resin modified glass ionomer varnish. Group (C): patients will receive a light cured giomer varnish.
Pre-operative procedures:
- Patients will be interviewed the oral health related quality of life questionnaire and it will be assessed prior treatment.
- Mineral density of the tooth will be measured using laser fluorescence.
- Teeth will be tested for sensitivity using recent validated test.
- Tooth color will be measured using vita easy shade.
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with molar incisor hypomineralization having at least one incisor and/or molar mildly affected.
- •Patient's age ranges from 6 to 10 years old.
- •The affected tooth has demarcated opacity without post eruptive enamel breakdown.
- •No cavitated lesion is related to the defect or previous restorative or preventive treatment.
- •The tooth is free from any symptoms of irreversible pulp inflammation.
排除标准
- •Children who are physically or mentally disabled or having any medical condition that will affect or complicate the treatment.
- •Incisors previously subjected to trauma that might lead to loss of tooth structure or compromised the pulp vitality.
- •Loss of tooth structure due to caries.
研究组 & 干预措施
Group A
Resin infiltration
干预措施: Resin infiltration (Drug)
Group B
Resin modified glass ionomer varnish
干预措施: Resin modified glass ionomer varnish (Drug)
Group C
Light cured giomer varnish
干预措施: Light cured giomer varnish (Drug)
结局指标
主要结局
Hypersensitivity
时间窗: It will be evaluated pre operative and at 1, 3,6,12 and 18 months follow up.
Hypersensitivity using VAS scale
Variation in mineral density
时间窗: It will be evaluated preoperatively and at 1, 3,6,12 and 18 months follow up.
Variation in mineral density of the enamel opacity using laser fluorescence.
次要结局
- Quality of life of the patient(It will be evaluated preoperatively and at 1, 3,6,12 and 18 months of follow up.)
- Parent Satisfaction(It will be evaluated preoperatively and at 1, 3,6,12 and 18 months of follow up.)
- Color change of the enamel opacity(It will be evaluated preoperatively and at 1, 3,6,12 and 18 months of follow up.)
研究者
Hagar Mahmoud Mohie
PhD researcher
Ain Shams University