The Impact of Minimally Invasive Restorative Techniques on Dental Pain in Pregnant Women: a Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Pain assessment
研究概览
简要总结
The aim of the present study was to compare the effectiveness of chemo-mechanical caries removal using Papacarie-Duo and Atraumatic Restorative Treatment (ART) in reducing dental pain in pregnant women.
详细描述
A randomized controlled clinical trial was conducted in 2019 and included 162 pregnant women visiting family health centers in Alexandria, Egypt with dental pain due to caries not extending to pulp who were randomly assigned into Papacarie-Duo group (n=82) and ART group (n=80) after stratification by number of treated surfaces
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
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant females in the first or second trimester
- •Having at least mild dental pain as identified by a score of at least 5mm on a Visual Analogue Scale (VAS) 100-mm-long
- •Having at least one carious lesion involving dentine clinically classified as a shallow or medium cavity. This cavity should be accessible to hand instruments (International Caries Detection and Assessment System (ICDAS) score= 5 or 6.
排除标准
- •Pregnant women with acute pulpitis, swelling or fistula.
- •Uncooperative patients.
- •Patients with severe gingivitis (Gingival Index (GI) score=3).
- •Patients who are unable to read and/or write and those who refused to participate.
研究组 & 干预措施
Papacarie-Duo
干预措施: Papacarie (Drug)
Atraumatic Restorative Treatment
干预措施: Atraumatic Restorative Treatment (Drug)
结局指标
主要结局
Pain assessment
时间窗: up to 6 months
Difference in pain was measured using Visual Analogue Scale (VAS). The scale is represented by a 100-mm-long horizontal line labeled "no pain" at one end and "worst pain" at the other end. Participants were asked to mark the place on the line representing their level of pain
Satisfaction with treatment
时间窗: up to 6 months
Satisfaction with treatment was assessed using two questions: the first question was immediately following treatment: "Was the treatment carried out according to your expectations?" The second question was after 6 months" "Has the treatment solved the problem of your teeth?" Each question was answered on a 10-point scale, with lower values indicating a negative perspective and higher values indicating a positive experience.
次要结局
- Time to remove caries(Procedure (Immediately while treatment))
研究者
Nourhan M.Aly
Assistant Lecturer of Dental Public Health
University of Alexandria