Evaluation of Antimicrobial Photodynamic Therapy and Minimal Intervention Associated With Deproteinization in Permanent Teeth With Molar Incisor Hypomineralization: Study Protocol for a Clinical, Controlled, Blinded Trial.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Change in retention of the restorative material in the cavity
研究概览
简要总结
Introduction: Molar Incisor Hypomineralization (MIH) is a qualitative defect of enamel development that occurs in the mineralization phase. MIH affects one or more permanent molars and, occasionally, permanent incisors. The aim of the proposed study is to evaluate the clinical effect of antimicrobial photodynamic therapy (aPDT) on permanent teeth with MIH through decontamination and sensitivity control. The longevity of the restorations will also be evaluated after the deproteinization procedure. Methods and analysis: Patients 8 to 12 years of age with permanent molars will be randomly allocated to three groups. Group 1: selective chemical-mechanical removal of carious dentinal tissue around the walls of the cavity with Papacárie Duo and a curette followed by the application of aPDT and deproteinization with Papacárie Duo; Group 2: selective removal of carious dentinal tissue around the walls of the cavity with a curette, followed by the application of aPDT and deproteinization with a 5% sodium hypochlorite solution; Group 3: selective removal of carious dentinal tissue using a curette. The selected teeth must have a carious lesion in the dentin and post-eruptive enamel breakdown on one or more surfaces with an indication for clinical restorative treatment. The teeth will subsequently be restored using a mixed technique with resin-modified glass ionomer cement and bulk-fill composite resin. The data will be submitted to descriptive statistical analysis. Associations with age and sex will be tested using either the chi-squared test or Fisher's exact test. Pearson's correlation coefficients will be calculated to determine the strength of correlations between variables. Comparisons of the microbiological results (colony-forming units) will be performed using ANOVA and the Kruskal-Wallis test. Kaplan-Meier survival analysis will be performed to assess the performance of the restorations.
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)
盲法说明
An independent assessor blinded to the allocation to the different groups will perform evaluations after 48 hours and at three-month intervals for a follow-up period of 12 months.
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children with no adverse systemic conditions;
- •At least one permanent first molar with MIH and active caries on the dentin with post-eruptive fracture on a single surface or multiple surfaces with an indication for restorative treatment; direct view and access; no clinical or radiographic signs or symptoms of pulpal involvement;
- •Hypomineralized enamel with opacities near the margins of the cavities;
- •Occurrence or non-occurrence of dentinal sensitivity.
排除标准
- •Clinically: carious lesion only involving the enamel, deficient restorations, small carious lesions in dentin (without access to manual excavator), hidden caries, clinical sign or symptom of pulpal involvement, clinical impossibility of restoration;
- •Radiographically: evidence of pulpal involvement;
- •Teeth severely affected by MIH without indication for restorative treatment;
- •Partially erupted teeth with MIH.
结局指标
主要结局
Change in retention of the restorative material in the cavity
时间窗: 48 hours after the restorative treatment and at three-months intervals for a period of 12 months of follow up.
The effects of deproteination on the longevity of the restoration will be evaluated using the modified USPHS index, in which retention, marginal integrity, marginaldiscoloration, anatomic form and secondary caries are evaluated.
次要结局
- Change in microbiological evaluation(Baseline and immediately after treatment.)
- Change in Dental Sensitivity(Baseline, 48 hours after the restorative treatment and at three-months intervals for a period of 12 months of follow up.)
研究者
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho