Retention Rate of Giomer S-PRG Filler Containing Pit and Fissure Sealant Applied With or Without Etching by Using Split Mouth Technique: Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- retention rate
研究概览
简要总结
The aim of this study is to evaluate the retention rate of Giomer S-PRG filler containing pit and fissure sealant applied with or without etching by using split mouth technique.with null hypothesis that Giomer S-PRG filler containing pit and fissure sealant applied either with or without etching will have the same retention rate.
详细描述
Study Settings:
The study will be carried out at the Conservative Dentistry Department, Faculty of Dentistry, Cairo University in Egypt. Ethical approval is taken from the Research Ethics Committee of the faculty of Dentistry, Cairo University. Signed informed consent is signed by each participant.
Recruitment:
Participants are recruited from the patients' flow at the clinics of the Conservative Dentistry Department of Faculty of Dentistry, Cairo university.
Eligibility Criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ICDAS score 0 or 1
- •Satisfactory oral hygiene
- •Normal salivary characteristics (consistency, pH, flow rate, buffering capacity)
- •Satisfactory cooperative behavior
- •Age between 15- 30 years old
- •Males or females
- •Subjects who signed informed consent
排除标准
- •ICDAS score > 1
- •Poor oral hygiene
- •Evidence of tempromandibular joint disorders or malocclusion
研究组 & 干预措施
Giomer pit and fissure sealant without etching
In the control group, an adequate amount of primer is applied onto the enamel surface with a microbrush, left undisturbed for 5 s and then air-dried gently to avoid blowing it away. Beautisealant is applied directly from the syringe into pits and fissures and light-cured for 10 s, according to the manufacturer's instructions.
干预措施: Giomer pit and fissure sealant without etching (Drug)
Giomer pit and fissure sealant with etching
In the intervention group, the same steps are done except for an additional initial etching step with phosphoric acid etching for 30 s (for the uncut enamel) before primer and sealant application.
干预措施: Giomer pit and fissure sealant with etching (Drug)
结局指标
主要结局
retention rate
时间窗: 3 months, 6months , 1 year
To assess the sealant retention rate either total retention, partial loss or total loss
次要结局
未报告次要终点
研究者
Manar abd elmageed ahmed
lecturer
Cairo University