A Comparison of the Effectiveness of Resin Infiltration Treatment Versus a Combined Treatment of Microabrasion and Resin Infiltration for the Management of Affected Incisors in Molar Incisor Hypomineralization (MIH) Cases
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Change in the aesthetics and amount of color masking of the lesion
研究概览
简要总结
The prevalence of molar incisor hypomineralization is relatively high. It has been reported that MIH-affected children experience a wide range of negative impacts because of having visible enamel opacities on their incisors whether these teeth show post eruptive breakdown or not. The management of MIH is challenging with a broad spectrum of treatment modalities being available. However, there are no clear guidelines available to aid in clinical decision making. Possible treatment options for anterior teeth with MIH include: Microabrasion, resin infiltration, tooth bleaching, etch-bleach and seal technique and composite restorations or veneers. It is believed that these methods could be used alone or in a combination of methods to achieve better aesthetic results.
For MIH affected-incisors microabrasion and resin infiltration are acceptable treatment options which could be used alone or in a combination. Accordingly, the aim of this study is to compare the clinical outcomes of using resin infiltration either alone or combined with microabrasion for the management of MIH affected incisors.
详细描述
The study will be conducted on a dental unit in postgraduate clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Egypt.The primary hypothesis of this study is that a resin infiltration and microabrasion combined treatment will result in better clinical outcomes than using resin infiltration alone. All treatment procedures will be carried out by the principal investigator.
36 patients will be included in the study. The teeth will be randomized into two groups according to the intervention. The study involves two types of interventions:
Group 1 (resin infiltration):
The treatment will follow the manufacturer's instructions (Icon, DMG, Hamburg, Germany). The procedure involves the application of Icon-Etch, Icon-Dry as well as Icon-Infiltrant. Followed by removal of excess and then polishing of the treated surfaces.
Group 2 (Micro-abrasion followed by resin infiltration):
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Selection bias: will be overcome by randomization and allocation concealment. Performance bias: will be overcome by standardized method of application by single operator.
Detection bias: will be overcome by blinding of the outcome assessor. Reporting bias: All the outcomes will be reported and published.
入排标准
- 年龄范围
- 7 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cooperative children aged between 7-16 years old
- •Children with MIH having enamel opacity involving at least one permanent incisor
- •MIH- affected incisors which did not receive any previous treatment
- •1/3 of the crown should be visible in the oral cavity
- •Lesions size should be more than 1mm
- •Healthy children
排除标准
- •Children with systemic diseases, allergies or any dental or facial anomaly other than MIH
- •Children aged < 7 or > 16 years old
- •Uncooperative children
- •MIH patients without the affection of the incisors or with compromised incisor esthetics due to tooth surface loss, traumatic dental injury or caries
- •MIH incisors which already received any kind of treatment
- •Lesions which are smaller than 1mm in size
结局指标
主要结局
Change in the aesthetics and amount of color masking of the lesion
时间窗: 12 months
Vita Easyshade Advance® spectrophotometer (Vita Zahnfabrik, Sackingen, Germany) will be used to evaluate the change in color of the teeth selected in the study before and after the treatment. L\*, a\*, and b\* values will be recorded for each tooth based on the CIEL\*a\* b\* color space. The value of color differences or color masking (∆E) will be clinically evaluated by the formula ∆E=\[(∆L\*)2+(∆a\*)2+(∆b\*). Color readings will be taken before, immediately after, 1, 3, 6, and 12 months after treatment.
次要结局
- Change in the patient's oral health related quality of life following the treatment: Child Perceptions Questionnaire CPQ 8-10/11-14(12 months)
研究者
Dina Shehab
Assistant lecurer
Cairo University