Use of the Er:YAG Laser in Conservative Dentistry: Evaluation of the Microbial Population in Carious Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Comparison of microbial load change after Er:YAG and conventional treatments
研究概览
简要总结
The aim of this study is to verify the quantitative and qualitative effect of Erbium dental laser therapy on microbial populations in carious lesions and to compare the laser therapy with traditional conservative therapies.
详细描述
Patients will be assessed and selected at the University Odontostomatology Clinic (COU) in Perugia; patients are considered eligible for enrolment if they are at least 18 years old and have a carious lesion on permanent teeth, cavitated and non-destructive, deepening to the middle third of the dentine and no further. The patients will be randomly assigned to two groups as follows: group A, control group, which includes treatment with traditional therapy; group B, intervention group, which includes treatment with Er:YAG laser therapy. For each patient, two salivary swabs will be taken on the cavity dentine of the carious lesion: one before and one after the treatments.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
To ensure confidentiality of the data, each subject will be assigned a serial number so that only one of the experimenters will be able to link a number to the corresponding person. In addition, a dedicated computer will be used for data collection and analysis, which will be set up to allow limited access with a password known only to one of the experimenters.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients of both sexes with at least 18 years of age and one cavitated non-destructive carious occlusal lesion of a permanent teeth, that deepens up to the middle third of the dentin and not beyond, confirmed by radiographic exam and without pulp involvement.
排除标准
- •patients that refused to sign the informed consent document;
- •children or individuals with less than 18 years;
- •pregnant subjects;
- •patients with syndromes or chronic systemic diseases;
- •patients who had used antibiotics within the previous three months or under pharmacological treatments;
- •patients with painful symptoms consistent with irreversible pulpitis or mobility and destructive carious lesions extending beyond the middle third of the dentin;
- •teeth with exposure of the dental pulp or periodontitis;
- •patients with caries on deciduous teeth;
- •patients with no cooperation during the radiographical exam and/or treatments.
结局指标
主要结局
Comparison of microbial load change after Er:YAG and conventional treatments
时间窗: Measuring before any treatment and after treatments, through study completion, an average of 6 months
Swabbing of two samples from the cavity floor of lesions: before any treatment and after treatments (laser and traditional). Quantitative evaluation of the microbial population, in terms of Colony Forming Unit (CFU) by seeding the swabs taken in various types of media (Chocolate Agar, CNA Agar, Haemophilus Agar, Sabouraud, McConkey Agar, Shaedler Agar) and analysing the changes from baseline CFUs before any treatment and after Er:YAG laser and conventional therapies (control group and intervention group), comparing the effects of the two different types of treatment .
Comparison of the effects of Er:YAG and conventional therapy in modifying the reduction of specific microbial species through mass spectrometry typing
时间窗: Measuring before any treatment and after treatments, through study completion, an average of 6 months
Qualitative evaluation of the microbial species grown by mass spectrometry typing (MALDI TOF MS, Biomèrieux) of colonies freshly collected on culture plates, and analysis of the changes from baseline growth before any treatment and after Er:YAG laser and conventional therapies (control group and intervention group), comparing the effects on the growth of specific microbial populations of the two different types of treatment .
次要结局
未报告次要终点
研究者
Guido Lombardo
University Researcher
University Of Perugia