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临床试验/NCT06641323
NCT06641323已完成不适用

Ozonized Gel vs Gaseous Ozone Against S. Mutans in Deciduos Molars Caries: Randomized Clinical Trial

University of Pavia2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Change in S. mutans counts

研究概览

简要总结

The aim of this study is to verify, through bacteriological analysis, the efficacy of reducing the bacterial load referred to the presence of Streptococcus Mutans in carious lesions of viable deciduous molars by application of gaseous ozone or ozonized gel.

Patients who meet the eligibility criteria and for whom the legal guardians have signed the informed consent, will undergo treatment of the carious lesion with gaseous ozone or ozonized gel. After selective removal of dentin, a bacterial sample will be taken from the carious surface with a sterile paper cone at time T0; then ozone will be applied for 30 seconds, the surface will be washed with sterile saline and dried with air, a second sample will be taken at time T2; finally, ozone will be applied for another 30 seconds, the surface will be washed with sterile saline and dried with air, a third sample will be taken at time T2.

Patients are then randomised into two groups:

Test group: gaseous ozone (Healozone X4) is applied to the carious lesion for 30 seconds and then for another 30 seconds.

Control group: ozone gel (GeliO3) will be applied to the carious lesion for 30 seconds and then for another 30 seconds.

Changes in the following indices will be assessed at the first visit and when the samples are taken at T0, T1, T2: compliance assessment (FLACC scale), sensitivity test (Schiff Air Index), assessment of lesion severity and extent (ICDAS), assessment of gingival inflammation (GI), assessment of plaque index (PI), assessment of severity of enamel erosion (Bewe index).

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients suffering from carious lesion on viable deciduous molar
  • patients' compliance

排除标准

  • patients with early loss of deciduous molars for carious lesions or orthodontic reasons
  • non-viable deciduous molars
  • deciduous molars with traumatic lesions

结局指标

主要结局

Change in S. mutans counts

时间窗: Baseline (T0), after 30 seconds (T1) and after 60 seconds (T2)

Evaluation of Colony forming units (CFU) of bacterials samples after treatment.

次要结局

  • Change in FLACC(Baseline (T0), and after 60 seconds (T2))
  • Change in Schiff Air Index(Baseline (T0), and after 60 seconds (T2))
  • Gingival Index (calculated on Ramfjiord teeth)(Baseline (T0))
  • Plaque Index (calculated on Ramfjiord teeth)(Baseline (T0))
  • ICDAS(Baseline (T0))
  • Basic Erosive Wear Examination(Baseline (T0))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Scribante

Associate Professor, Principal Investigator

University of Pavia

研究点 (2)

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