Laser Used in the Treatment of Hypomineralized Occlusal Lesions in Teeth Enamel Affected by MIH: a Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Evaluation of clinical signs change in the progression of caries lesion and / or occlusal surface wear during the follow-up
研究概览
简要总结
Background: Nowadays an increase in the incidence of teeth affected by molar incisor hypomineralisation (MIH) has been observed. There are several treatment modalities that depend on the degree of severity of the defect, such as preventive procedures, restorative and even dental extractions. However, these changes may affect the retention and longevity of restorative materials. Therefore, the aim of this study is to evaluate the use of diode laser irradiation for the treatment of occlusal surfaces of moderate lesions in permanent first molars affected with MIH as a preventive method for dental caries and occlusal wear, besides verifying the discomfort of the treatment by patients. Methods: For this, a controlled and randomized study, with parallel groups, will be conducted comparing the treatment with diode laser and sealing with high viscosity glass ionomer cement in the teeth affected by the MIH. Participants will be assessed at baseline and after 1 week, 1, 6, 12, 18 and 24 months. As the main outcome, the presence of dentin caries lesion and /or occlusal surface wear included in the study with dentin involvement will be evaluated. A visual examination for caries detection will be done using the ICDAS, using the index based on classification in the United States Public Health Service - Modified (USPH) for evaluation of sealed teeth and impression of impacted teeth for quantitative analysis of the lesions. Other outcomes such as patient satisfaction with treatment, patient discomfort, impact on quality of life and participant perception, as well as the duration and cost of treatment, as well as their cost-efficacy, will also be evaluated. Multilevel statistical analyzes will be performed to verify the efficacy 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
- Prevention
- 盲法
- None
盲法说明
No masking
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
- •Children who present at the first permanent molar with occlusal surface affected with light or moderate severity of MIH
- •Children between 6 and 10 years old
排除标准
- •Teeth that present restorations
- •Teeth that presente sealants
- •Enamel malformations that are specific to some syndromes
- •Hypomineralized enamel affected by the ingestion of fluoride during enamel development
结局指标
主要结局
Evaluation of clinical signs change in the progression of caries lesion and / or occlusal surface wear during the follow-up
时间窗: All surfaces will be examined after previous cleaning with prophylactic paste and water and a Robson brush, with lighting and after air drying and 1, 6, 12, 18 and 24 months after
The main outcome will be the presence of changes in clinical signs in relation to the progression of carious lesions and / or occlusal surface wear included in the study with dentin involvement through ICDAS, photographs, radiographic examination and the index based on the classification in the United States Public Health Service - Modified (USPH).
次要结局
- Self-reported discomfort using Wong Backer face scale after the treatment(This evaluation will be performed before starting the treatment with laser or with high viscosity glass ionomer and 2 minutes after the treatment is performed])
- Hypersensitivity to dentin(This evaluation will be performed before treatment, 1 week, 1, 6, 12, 18 and 24 months after inclusion)
- Evaluation of patient's perception of satisfaction regarding their oral health(For this, an external examiner will apply the questionnaire prior to randomization and on 1, 12 and 24 month return visits.)
- Satisfaction in relation the treatment using VAS scale(This evaluation will be applied after 1 week of treatment, 1, 12 and 24 months and will not be identified by name and will be done in the absence of the operators so as not to restrain the subject from expressing their actual opinion.)
- Costs of each consultation performed through study completion(The time spent in each of the sessions will be timed by an external examiner not participating in the exams, who will also note the number of visits of each participant. The data will be collected at all return visits (1 week, 1, 6, 12, 18 and 24 months))
研究者
Luciana Pion Antonio
Principal investigator
University of Sao Paulo