Controlled Clinical Trial Of The Use Of Hall Technique In Deciduous Molars Affected By Extensive Caries Lesions. Follow Up Of 12 Months.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Changes in the Longevity Of Restorations
研究概览
简要总结
Despite preventive treatments and the promotion of oral health, dental caries is one of the most prevalent chronic diseases in the population and treatment of caries lesions in deciduous teeth is a fundamental procedure aimed at increasing the resistance of the remaining tooth structure to preserve the permanent dentition. The present study aims to make a clinical evaluation of the Hall Technique compared to direct restorations with universal adhesives and bulk fill resins in large destruction of deciduous teeth. 90 children between 5 and 10 years old, healthy, of both sexes, without distinction of race, enrolled in the clinics of Universidade Metropolitana de Santos-UNIMES will be selected. The in-office treatments will be carried out by a trained researcher, according to the manufacturer's instructions for each material and scientific evidence on the respective topic. Participants will be divided into 03 groups according to the proposed treatments. Group 1 - Universal adhesive restorative procedure + condensable bulk fill resin; Group 2 - Hall Technique with Shofu steel crowns and Group 3 - Steel crown with conventional technique. The evaluated outcomes will be: effectiveness of the technique and longevity 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
Clinical and radiographic evaluations of the complete removal of the carious lesion will be performed by two calibrated examiners blinded to the allocation of teeth to the different groups. Also, calibrated examiners, who will not be performing the restorations and therefore will be blind to the groups, will perform the assessment.
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy child, without systemic changes;
- •Good behavior;
- •Clinically, present at least two deciduous molars with caries in dentin involving more than three surfaces, with vision and direct access, without signs and symptoms of pulp involvement.
排除标准
- •Children with any serious systemic disorder;
- •Lack of cooperation.
- •Clinically present at least one deciduous molar with carious lesion in the dentin involving signs and symptoms of pulpal involvement.
结局指标
主要结局
Changes in the Longevity Of Restorations
时间窗: Three, 6 and 12 months after treatment.
Steel restorations and crowns will be classified according to the criteria in the following scores: FDI criterion (clinically very good, clinically good, clinically sufficient/satisfactory, clinically unsatisfactory, clinically poor).
次要结局
- Changes in Salivary PH(Baseline, 6, and 12 months after treatment.)
- Technique Perfomance Time Duration(During the procedure.)
- Changes in the biofilm index(Baseline, 3, 6, and 12 months after treatment.)
- Changes in The Presence of Caries Lesions(Baseline, 6, and 12 months after treatment.)
研究者
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho