Comparison of Three Restorative Protocols in Teeth With Molar-Incisor Hipomineralization (MIH): a Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Treatment satisfaction as assessed by VAS scale (Index 0 to 10)
研究概览
简要总结
Molar-Incisive Hipomineralization (MIH) is defined as a qualitative change in tooth enamel of systemic origin, which affects one or more permanent first molars, and may or may not involve permanent incisors. MIH has several clinical repercussions, such as presence of hypersensitivity, difficulty in local anesthesia, reduction of restorations longevity, among others, making it difficult to perform dental treatment. Therefore, the present study will evaluate, through a randomized controlled clinical study, three restorative protocols for the treatment of severe MIH (with post eruptive enamel fracture and dentin exposure). The following groups will be evaluated: direct restoration with composite resin; restoration with composite resin with diode laser application and temporary restoration with glass ionomer cement followed by restoration with composite resin). The restorations will be evaluated after 1 week, 1, 6, 12, 18 and 24 months. The main outcome will be evaluation of restoration longevity, presence of caries lesion and wear of the restoration surface. Other outcomes such as patient satisfaction with treatment, patient discomfort, anxiety, assessment of dentin sensitivity and impact on participants' quality of life, as well as the duration and cost of treatment, as well as their cost-effectiveness ratio will also be evaluated . Multilevel statistical analyzes will be performed to verify the effectiveness of diode laser treatment compared to sealing, in addition to possible factors associated with this efficacy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •At least one permanent first molar with occlusal surface with severe MIH grade (with post eruptive enamel fracture and dentin exposure), it may not be reported hypersensitivity in the selected tooth.
排除标准
- 未提供
结局指标
主要结局
Treatment satisfaction as assessed by VAS scale (Index 0 to 10)
时间窗: After 1 week of treatment, 1, 12 and 24 months.
After 1 week of treatment, 1, 12 and 24 months, the caregiver will be asked to respond about the satisfaction regarding the care (treatment and returns) received. He should classify his satisfaction using the VAS scale with indexes from 0 to 10, with 0 being the worst treatment evaluation and 10 being the best.
Discomfort referred by the children assessed by Wong-Baker Facial Scale (Very smiling to very sad)
时间窗: On treatment day
In order to assess the discomfort reported by the children in relation to the type of treatment received, the same timekeeping operator will apply the Wong-Baker Facial Scale to the patient, which is composed of six figures with equidistant faces. that the first one is very smiling and the expressions are changing, until the last one is very sad.
Longevity of restorations
时间窗: 24 months.
The main purpose will be the longevity of the desserts in elaborate compounds, according to the three protocols. Images should be analyzed and scanned. Radiographic examination and digital radiography. After 6, 12 and 24 months.
Anxiety Assessment
时间窗: On treatment day
For the assessment of anxiety in the study children, the Children's Fear Survey Schedule-Dental Subscale will be used
Quality of life assessed by Child Perceptions Questionnaire 8-10 (CPQ8-10) (Assessed by questions)
时间窗: On treatment day
To assess the impact of MIH on children's quality of life, the Child Perceptions Questionnaire 8-10 (CPQ8-10), specially developed for children aged 8-10 years and validated in the Portuguese language. This scale was assessed through questions and answers to a children's quality of life.
次要结局
- Evaluation of the visible biofilm accumulated on the occlusal surface(On treatment day)
- Assessment of eruption degree(On treatment day)
- Evaluation of the caries experience(On treatment day)
- Presence of biofilm visible(On treatment day)
- Evaluation of the presence of visible biofilm on the buccal surfaces of the molars to be evaluated(On treatment day)
- Evaluation of lesion extension(On treatment day)
- Cost of procedures(On treatment day)
- Socioeconomic questionnaire(On treatment day)
研究者
Vicioni-Marques, F
Comparison of Three Restorative Protocols in Teeth With Molar-Incisor Hipomineralization (MIH): a Randomized Controlled Clinical Study
University of Sao Paulo