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临床试验/NCT06592885
NCT06592885尚未招募不适用

Evaluation of Success of Hall Technique Versus Atraumatic Restorative Treatment in the Management of Carious Primary Molars: a Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年10月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
68
试验地点
1
主要终点
Clinical Success, Assessed by clinical examination

研究概览

简要总结

Dental caries is a natural process by which bacteria in the biofilm causes fluctuations in the pH, which leads to enamel erosion and result in visible lesions. If left untreated, caries will progress and result in pain, abscess, and systemic infection, leading to functional and/or psychosocial impairment which is a serious problem Caries is, in fact, the most prevalent childhood disease in the world and is most prominent among low-economic populations. So, the main goal is to minimize Dental caries as much as possible by applying preventive measures to reduce the occurrence and progression of dental caries.

In that scope, both Atraumatic Restorative Treatment (ART) and the Hall Technique (HT) were created as part of Minimal Invasive Dentistry (MID) to slow the downward restorative spiral and reduce discomfort during the treatment as neither of which requires the administration of local anesthesia nor the use of rotary instruments.

According to a retrospective analysis, utilizing the Hall technique to seal cavities performed much better than using conventional restorations. statistically and clinically during 10 years of follow-up.

Since ART is associated with lower levels of anxiety, pain, and discomfort than traditional dentistry procedures, it has become widely employed in pediatric dentistry. Despite having reduced survival rates in multiple-surface restorations, ART is still regarded as a viable, evidence-based choice for treating and preventing caries lesions in primary posterior teeth since it is a quick, inexpensive, and comfortable procedure for the patient.

详细描述

One of the most prevalent childhood diseases, dental caries, affects up to 90% of children globally, especially those from the underprivileged group.

WHO estimates that Egypt has a 60% prevalence of dental caries. Early childhood caries has a negative effect on a child's oral health-related quality of life. Both the family and the child are directly affected.

The ideal treatment of carious lesions has been the subject of recent revolutions. Traditional restorative methods, which focused on completely removing carious tooth tissue and then placing a restoration have been replaced by more biological and minimally invasive methods that concentrate on controlling biofilms and disrupting the cariogenic biofilm environment to stop caries.

The Hall Technique (HT) supports this theory. Without any dental preparation or caries removal, a preformed metal crown (PMC) is simply fixed to the carious tooth using glass ionomer cement (GIC). The cariogenic biofilm beneath the cap is sealed.

The Hall technique of stainless- steel crown placement has proved to be a viable restorative option for carious primary molars resulting in its successful exfoliation.

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
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age: From 4 to 6 years.
  • Caries in primary molars within enamel/dentin with vital pulp.
  • Healthy children.
  • Cooperative children.

排除标准

  • Presence of signs and symptoms of necrosis.
  • Root caries.
  • History of Spontaneous pain.

结局指标

主要结局

Clinical Success, Assessed by clinical examination

时间窗: From enrollment to the end of treatment at 12 months (with follow up at 3-6-9-12 months)

* Standard clinical criteria will be used to determine whether a restoration (ART/HT) was successful or not in terms of having a satisfactory restoration that requires no further intervention and also the absence of any signs or symptoms of pulp damage. * Measuring unit is Binary (Yes/No)

次要结局

  • Post-operative pain and discomfort(Measured immediately after placement of SSC or restoration)
  • Child Behavior(Measured immediately after placement of SSC or restoration)
  • Child Anxiety(Measured immediately after placement of SSC or restoration)
  • Canine overbite: HT(Measured in millimeters immediately after placement of pre-fabricated stainless steel crown (SSC))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariam Atef Ahmed

Principal invistigator

Cairo University

研究点 (1)

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