Er:YAG Laser Effects on Microbial Population in Conservative Dentistry
2021年2月21日 更新者：Guido Lombardo、University Of Perugia
Use of the Er:YAG Laser in Conservative Dentistry: Evaluation of the Microbial Population in Carious Lesions
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
33
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Perugia、意大利、06132
- University Dental Clinic (C.O.U., Centro Odontostomatologico Universitario) of the University of Perugia
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Er:YAG laser therapy group
The removal of caries was performed with Er:YAG laser (Doctor Smile, Lambda SRL,Italy) with BOOST handpiece to cut the enamel and open the cavity, and 90° handpiece to remove the carious dentin with tips of 800 µ in diameter and 8 mm or 12 mm in length, in relation to the depth and distance of the lesion.
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Selected Er:YAG settings: "enamel removal" program for adult, with "normal" modality (frequency: 20 Hz, energy: 400 mJ, power: 8.0 W, air: 80%, water: 60%) and "dentin removal" program for adult, with "normal" modality (frequency: 20 Hz, energy: 200 mJ, power: 4.0 W, air: 90%, water: 30%)
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无干预：Traditional therapy group
The removal of caries was performed with manual and rotating instruments, such as dentin spoon (ASA Dental S.p.a.), turbine (NSK Dental Italy S.r.l.) with diamond burs (Kerr Dental Italia S.r.l.) to cut the enamel and open the cavity and drill handpiece (KaVo Dental Italia S.r.l.) with tungsten carbide burs (Kerr Dental Italia S.r.l.) to remove the infected dentin.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Comparison of microbial load change after Er:YAG and conventional treatments
大体时间：Measuring before any treatment and after treatments, through study completion, an average of 6 months
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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 .
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Measuring before any treatment and after treatments, through study completion, an average of 6 months
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Comparison of the effects of Er:YAG and conventional therapy in modifying the reduction of specific microbial species through mass spectrometry typing
大体时间：Measuring before any treatment and after treatments, through study completion, an average of 6 months
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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 .
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Measuring before any treatment and after treatments, through study completion, an average of 6 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Stefano Cianetti、Department of Medicine and Surgery
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年9月7日
初级完成 (实际的)
2020年10月5日
研究完成 (实际的)
2020年12月18日
研究注册日期
首次提交
2021年2月14日
首先提交符合 QC 标准的
2021年2月21日
首次发布 (实际的)
2021年2月25日
研究记录更新
最后更新发布 (实际的)
2021年2月25日
上次提交的符合 QC 标准的更新
2021年2月21日
最后验证
2021年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Er:YAG Laser的临床试验
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Cork University HospitalFotona d.o.o.未知