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临床试验/NCT04619264
NCT04619264已完成2 期

Impact of Minimally Invasive Restorative Techniques on Pregnant Women Oral Health Related Quality of Life: a Randomized Clinical Trial

Nourhan M.Aly1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2019年1月10日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

干预措施: Papacarie (Drug)

Atraumatic Restorative Treatment

Active Comparator

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

发起方
Nourhan M.Aly
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nourhan M.Aly

Assistant Lecturer of Dental Public Health

University of Alexandria

研究点 (1)

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