The Effect of Ozone Application Before Fissure Sealants: a Split Mouth Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Sealants failure
研究概览
简要总结
Decay is a multifactorial infective degenerative disease of hard dental tissues, caused by Streptococcus mutans and Lactobacillus forming the bacterial biofilm of teeth surfaces. Decays generally evolve in fissures and pits of secondary molars. Pits and fissure sealants prevent decays if performed in two years from eruption. Ozone has bactericidal effect and remineralizing capacity on enamel.
The aim of this study is to assess the effectiveness of ozone application before sealants in increasing their duration in time.
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)
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first or second secondary molars to be sealed
- •possibility to isolate with rubber dam both the teeth involved
- •no clear signs of pigmentations
- •good general health
排除标准
- •latex allergy
- •epilepsy or other severe neurological pathologies
- •psychiatric disease
- •excessive sensibility to electrical current
- •severe asthma
- •enamel disorders, such as amelogenesis imperfect, white spots, fluorosis or Molar Incisors Hypomineralization
研究组 & 干预措施
Pits and fissure sealants
干预措施: Pits and fissure sealants (Other)
Ozone therapy
Ozone application before pits and fissure sealants
干预措施: Pits and fissure sealants (Other)
Ozone therapy
Ozone application before pits and fissure sealants
干预措施: Ozone (Device)
结局指标
主要结局
Sealants failure
时间窗: 12 months after sealant
Frequency of sealed failure defined as presence of to one or more of these outcomes: Marginal fissure; Sealant fracture; Decay; Marginal pigmentations; Sealant detachment Evaluation of the relative frequency of the different causes of failure
次要结局
- Sealants failure(24 months after sealant)
- Secondary decay in failed sealants(24 months after sealant)
- Sealants failure(6 months after sealant)
- Secondary decay in failed sealants(6 months after sealant)
- Secondary decay in failed sealants(12 months after sealant)