In Vivo Evaluation of the Antimicrobial Activity of Diamine Silver Fluoride and Potassium Iodide on Dentin Carious Lesions in Kuwaiti Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 主要终点
- antibacterial activity measured by total viable counts after treatment
研究概览
简要总结
Dental caries is an infectious disease mediated by a consortium of microbes in the oral cavity. The disease is characterized by demineralization of the tooth, if untreated, it leads to cavitation, discomfort, pain and eventual tooth loss. Frequently, complete caries removal of dentine carious lesions leads to exposure of the pulp affecting its vitality. Therefore, it is crucial that vitality of the teeth is preserved causing little damage to the pulp. Different approaches have been used to reduce or eliminate microorganisms underneath the restorations. Chlorhexidine has a strong antibacterial effect, particularly on planktonic bacteria. Its effect on bacterial biofilms is compromised, however The objective of this study is to examine the in vivo effect of diamine silver fluoride, potassium iodide and their mixture on bacteria present in deep carious lesions. Dentine samples from 5 carious lesions from each of 5 patients before and after treatment with test agents will be collected in pre-reduced sterile Ringer's solution and processed for microbiological evaluation. The samples after serial dilution and plating will be incubated in aerobic, anaerobic and CO2 atmosphere for 2-5 days. Colony forming units will be enumerated and the effect of antibacterial agents in question on the bacterial viability in carious lesions will be assessed.
详细描述
Study subjects:
Study subjects (n=5) will be recruited from the pool of patients attending Kuwait University Dental Clinic. Informed written consent will be obtained from all subjects. An approval for using human subjects in the study will be obtained from the Ethics Committee of HSC, Kuwait University.
Inclusion criteria:
- Patient is able to give informed consent
- Tooth with moderate size caries lesions, penetrate through ½ of dentine thickness
- Suitable for the placement of a Vitrabond lining
- Restoration is part of a current and approved treatment plan
Exclusion criteria:
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient should be able to give informed consent.
- •had at least 5 teeth with moderate size caries lesions (for 5 treatments), to be exact with the lesion size.
- •the carious lesion should at least penetrate to the inner ½ of dentine thickness.
- •the lesion should be suitable for the placement of a Vitrabond lining of 0.5-1.0 mm
- •permanent restoration should be a part of a current and approved treatment plan
排除标准
- •Inability of the patient to give informed consent.
- •teeth had received temporary restoration
- •isolation with rubber dam is not possible.
- •if cavity preparation was contaminated due to gingival bleeding
- •All patients were placed under a follow up system for the purpose of addressing any complaints that might result from the sampling procedure.
结局指标
主要结局
antibacterial activity measured by total viable counts after treatment
时间窗: Through study completion, an average of 3 months
次要结局
未报告次要终点
研究者
Maribasappa Karched
Assistant Professor
Kuwait University