Impact of Minimally Invasive Restorative Techniques on Pregnant Women Oral Health Related Quality of Life: 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
- Change in Oral Health Related Quality of Life
研究概览
简要总结
Aim of the study was to compare the effect of chemo-mechanical caries removal methods using Papacarie-Duo and alternative restorative treatment (ART) on the Oral Health Related Quality of Life (OHRQoL) of 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 mild to moderate dental pain due to caries. Participants were randomly assigned into Papacarie-Dup group (n=82) and ART group (n=80). The outcome variable was percent change in OHRQoL measured by OHIP-14.
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
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Having at least one carious lesion involving dentine with lesion accessible to hand instruments (International Caries Detection and Assessment System score= 5 or 6).
- •Suffering from at least mild dental pain as identified by a score of at least 5mm on a Visual Analogue Scale (VAS) 100-mm-long.
排除标准
- •Pregnant women with acute pulpitis, swelling or fistula.
- •Uncooperative patients 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 (Procedure)
结局指标
主要结局
Change in Oral Health Related Quality of Life
时间窗: up to 6 months
This was assessed by measuring changes between the Oral Health Impact Profile-14 (OHIP-14). The OHIP-14 includes 14 questions in seven dimensions with two questions for each dimension: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. Responses to the OHIP-14 items were measured on a 5-pont Likert scale ranging from never = 0; hardly ever = 1; occasionally = 2; fairly often = 3; to very often = 4. The OHIP-14 score is the sum of the scores of the 14 statements and ranges from 0 to 56 and from 0 to 8 for each dimension with higher scores indicating higher frequency of negative impact.
Retention of the final restoration
时间窗: up to 6 months
The scoring system was as follows: 0=present, without defect; 1=present, small defects on the margin measuring less than 0.5 mm in depth, with no need for repair; 2=present, small defects on the margin measuring 0.5 to 1.0 mm in depth, with need for repair; 3=present, gross defects on the margin measuring 1.0 mm or more in depth, with need for repair; 4=absent, restoration completely lost, need for treatment; 5=absent, other treatment had been performed for some reason; 6=tooth absent for some reason; 7=present, wear on surface less than 0.5 mm, with no need for replacement; 8=present, wear on surface greater than 0.5 mm, with need for replacement; 9=diagnosis impossible. Restorations having a score of 0, 1 or 7 were considered successful and those receiving a score of 2, 3, 4 or 8 were considered failures.
次要结局
未报告次要终点
研究者
Nourhan M.Aly
Assistant Lecturer of Dental Public Health
University of Alexandria
