Evaluation of Three Different Approaches Using Prolonged Resin Infiltration on Demarcated Enamel Opacities in Incisors Affected With Molar Incisor Hypomineralization: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Color Change
研究概览
简要总结
Molar incisor hypomineralization (MIH) is a condition which involves enamel hypomineralization of one to four first permanent molars with or without permanent incisors. Affected permanent incisors present with demarcated enamel opacities which cause esthetic and psychological problems to patients with MIH. Microabrasion and etch-bleach surface treatment can provide easier, conservative, and biologically driven treatment approach compared to macroabrasion prior to prolonged resin infiltration for treating enamel opacities in incisors of MIH patients.
The aim of this study is to evaluate the effect of microabrasion and etch-bleach surface treatment compared to macroabrasion prior to prolonged resin infiltration on esthetic appearance of permanent incisors affected with demarcated enamel opacities in MIH patients.
详细描述
In this randomized controlled trial, patients aged 8-14 years suffering from demarcated enamel opacities in permanent incisors of MIH patients will be randomly divided into three groups according to surface treatment.
The first group will receive microabrasion, the second group will receive microabrasion and etch-bleach surface treatments while the third group will receive macroabrasion surface treatment. Resin infiltration will be then applied to all groups with prolonged infiltration time for 30 minutes.
Color changes will be assessed using Vita easy shade whereas oral health related quality of life will be assessed using Child Oral-Health-Related Quality of Life Questionnaire. Assessment will be done before, immediately after; and 1, 3, 6 and 12 months after treatment protocol in all groups.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cooperative healthy male and female children aged 8 to 14 years.
- •MIH diagnosed patients according to the criteria of European Academy of Pediatric Dentistry (EAPD) with demarcated enamel opacity that caused esthetic discomfort to them and their guardian, involving at least one maxillary or mandibular permanent incisor.
- •At least one-third of the affected tooth crown should be visible in the oral cavity.
排除标准
- •Children with behavioral, cognitive, physical, or medical conditions that will affect or complicate the treatment.
- •Other developmental defects of dental enamel rather than MIH (i.e. dental fluorosis, enamel hypoplasia, amelogenesis imperfecta or Turner's tooth)
- •Loss of tooth structure due to post-eruptive enamel breakdown or caries.
- •Periodontal disease of the affected tooth.
- •Incisors previously subjected to trauma that might lead to loss of tooth structure or compromise the pulp vitality.
- •Previous preventive, restorative or orthodontic treatment on the affected tooth.
结局指标
主要结局
Color Change
时间窗: Preoperatively - Immediately postoperatively - 1, 3, 6 12 months postoperatively
Evaluating color change of the demarcated enamel opacity in permanent incisors of MIH patients using Vita easy shade.
次要结局
- Oral health related quality of life(Preoperatively - Immediately Postoperatively - 1, 3, 6, 12 months postoperatively)
研究者
Mayada Hefnawy
Assisstant Lecturer
Ain Shams University